title: Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

summary: The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.

ReferenceCitation: Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142 . Epub 2008 Jul 31.

location_country:
Spain
Italy
Austria
Russian Federation
United Kingdom
Canada
Switzerland
United States
France
Germany


type: EudraCT Number

title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.

lead_sponsor: Novo Nordisk A/S

location_country:
United Kingdom
Netherlands
Finland
Sweden
United States
France
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

summary: This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Portugal
Spain
Italy
United Kingdom
Canada
Thailand
Puerto Rico
United States
France
Germany


title: Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

summary: The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. Epub 2007 Jul 2.

lead_sponsor: R-Pharm

location_country:
Netherlands
Argentina
Canada
Sweden
United States
France
South Africa
Mexico
Norway
Germany


title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.

summary: This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

ReferenceType: derived

ReferenceCitation: Levin NW, Fishbane S, Cañedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. Erratum in: Lancet. 2008 Feb 2;371(9610):386.

location_country:
Spain
Italy
Canada
Switzerland
United States
France
Norway
Germany


title: An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039

summary: The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

ReferenceCitation: van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Spain
Ireland
Austria
Italy
Netherlands
Canada
United Kingdom
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Texas Oncology at Medical City Dallas Hospital

location_facility: Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

location_facility: Washington University School of Medicine

location_facility: University Hospital of Salamanca, Hematology Dept

location_facility: Uniklinikum Muenster, Medizinische Klinik und Poliklinik A

location_facility: University of Pennsylvania Cancer Center

location_facility: Johannes-Gutenberg-University Medical School, Department of Medicine III

location_facility: St. Vincent's Comprehensive Cancer Center

location_facility: Azienda Ospedaliera, S. Giovanni Battista

location_facility: Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology

location_facility: University of Erlangen-Nurenberg, Division of Hematology/Oncology

location_facility: Hackensack University Medical Center, David Jurist Research Building

location_facility: Hospital Clinico Universitario de Barcelona, Hematologia

location_facility: Weill Medical College of Cornell University, NY Presbyterian Hospital

location_facility: Medical University Clinic (Oncology/Haematology)

location_facility: Belfast City Hospital, Haematology Department

location_facility: Huddinge University Hospital M54, Department of Haematology

location_facility: Lombardi Cancer Center, Georgetown University Medical Center

location_facility: Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

location_facility: C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie

location_facility: Division of Hematology/Stem Cell Transplant

location_facility: Leeds General Infirmary, Department of Haematology

location_facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center

location_facility: Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet

location_facility: Universitatsklinikum Charite Medizinische Klinik und Poliklinik

location_facility: Charlotte Hematology Oncology Associates

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1

location_facility: McGill University Clinical Research Program

location_facility: University of Rochester Medical Center, James P. Wilmot Cancer Center


summary: The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.

status: Withdrawn

lead_sponsor: Schering-Plough

location_country:
United States
Canada
France

location_facility: QE II Health Sciences Centre, New Halifax Infirmary

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Centre Hospitalier de Lagny-Marne La Vallee

location_facility: University of Michigan, Dept. of Internal Medicine

location_facility: Sunnybrook & Women's College Health Sciences Center

location_facility: University of Chicago - Section of Cardiology

intervention_type: Procedure

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

lead_sponsor: Abbott

location_country:
Poland
Spain
Greece
Austria
Australia
Ireland
Canada
Italy
Netherlands
New Zealand
Sweden
Switzerland
United States
France
South Africa
United Kingdom
Belgium
Germany

location_facility: Albany Medical Center South Clinical Campus

location_facility: Klinik Und Poliklinik für Urologie und Kinder

location_facility: Institute Of Cancer Studies - University of Birmingham

location_facility: Chefarzt Urologische Klinik - Universitätsspital Zürich

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Universitätsklinikum Carl Gustav Carus an der

location_facility: Winship Cancer Institute Emory University

location_facility: The Institute Of Cancer Research - Royal Marsden Hospital

location_facility: Dept of Veteran's Affairs North Texas Healthcare System

location_facility: St. Vincent's Medical Center - Staten Island

location_facility: Clinical Research Centre - St Georges Hospital

location_facility: Urologische Klinik Und Poliklinik Grosshadern

location_facility: University Of Natal - Nelson R Mandela School of Medicine

location_facility: Hillcrest Urological Medical Group, Inc.

location_facility: The University Of North Carolina At Chapel Hill

location_facility: Clinica Urologica I - Università di Bari

location_facility: Istituto Nazionale per la Ricerca sul Cancro -IST

location_facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

location_facility: Clinica Urologica - Università Di Milano

location_facility: Landesklinik fur Urologie und Andrologie

location_facility: University Of Washington School Of Medicine


type: Other Identifier

title: A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more effective with or without BMS-275291 for non-small cell lung cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer.

study_start_date_type: Actual

ReferenceCitation: Bradbury PA, Twumasi-Ankrah P, Ding K, et al.: The impact of brain metastases on overall survival (OS) in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) clinical trials (CT) in advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-8075, 2009.

ReferenceCitation: Asmis TR, Ding K, Seymour L, Shepherd FA, Leighl NB, Winton TL, Whitehead M, Spaans JN, Graham BC, Goss GD; National Cancer Institute of Canada Clinical Trials Group. Age and comorbidity as independent prognostic factors in the treatment of non small-cell lung cancer: a review of National Cancer Institute of Canada Clinical Trials Group trials. J Clin Oncol. 2008 Jan 1;26(1):54-9. doi: 10.1200/JCO.2007.12.8322.

ReferenceCitation: Wheatley-Price P, Le Maître A, Ding K, Leighl N, Hirsh V, Seymour L, Bezjak A, Shepherd FA; NCIC Clinical Trials Group. The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials. J Thorac Oncol. 2010 May;5(5):640-8. doi: 10.1097/JTO.0b013e3181d40a1b.

ReferenceCitation: Hicks LK, Cheung MC, Ding K, Hasan B, Seymour L, Le Maître A, Leighl NB, Shepherd FA. Venous thromboembolism and nonsmall cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group trials. Cancer. 2009 Dec 1;115(23):5516-25. doi: 10.1002/cncr.24596.

ReferenceCitation: Douillard JY, Peschel C, Shepherd F, Paz-Ares L, Arnold A, Davis M, Tonato M, Smylie M, Tu D, Voi M, Humphrey J, Ottaway J, Young K, Vreckem AV, Seymour L. Randomized phase II feasibility study of combining the matrix metalloproteinase inhibitor BMS-275291 with paclitaxel plus carboplatin in advanced non-small cell lung cancer. Lung Cancer. 2004 Dec;46(3):361-8.

ReferenceCitation: Leighl NB, Paz-Ares L, Douillard JY, Peschel C, Arnold A, Depierre A, Santoro A, Betticher DC, Gatzemeier U, Jassem J, Crawford J, Tu D, Bezjak A, Humphrey JS, Voi M, Galbraith S, Hann K, Seymour L, Shepherd FA. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18. J Clin Oncol. 2005 Apr 20;23(12):2831-9.

ReferenceCitation: Leighl NB, Shepherd F, Paz-Ares L, et al.: Randomized phase II-III study of matrix metalloproteinase inhibitor (MMPI) BMS-275291 in combination with paclitaxel (P) and carboplatin (C) in advanced non-small cell lung cancer (NSCLC): NCIC-CTG BR.18. [Abstract] J Clin Oncol 22 (Suppl 14): A-7038, 626s, 2004.

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

location_country:
Poland
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Memorial Hospital Cancer Center - Chattanooga

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Central Georgia Hematology Oncology, P.C.

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: University of Arkansas for Medical Sciences

location_facility: Stadisches Krankenhaus Martha Maria Halle-Dolau

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Division of Medical Oncology - Vanderbilt

location_facility: University of Oklahoma Health Sciences Center

location_facility: Baptist Regional Cancer Center - Knoxville

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Cancer Care Ontario-Hamilton Regional Cancer Centre

location_facility: Hospital Universitario Marques de Valdecilla


title: Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

summary: The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

ReferenceCitation: Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)

ReferenceCitation: Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Canada
United States
France
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Univ of California - Davis Med Ctr / CARES

location_facility: Univ of Texas Southwestern Med Ctr of Dallas

location_facility: Clinical Malattie Infettive / Univ Modena

location_facility: St Vincents Hosp / Clinical Research Program

location_facility: Community Research Initiative of South Florida

location_facility: Houston Clinical Research Network / Div of Montrose Clinic

location_facility: Louisiana State Univ Med Ctr / HIV Outpatient Clinic

location_facility: Yale Univ School of Medicine / AIDS Program


title: A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.

ReferenceCitation: Jansen J, Vermorken JB, Boote D, et al.: Cost-effectiveness analysis of the EORTC 24971 (TAX 323) trial comparing docetaxel plus cisplatin and 5-fluorouracil versus standard treatment (cisplatin and 5-fluorouracil) as induction chemotherapy followed by radiation therapy in locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 25 (Suppl 18): A-6090, 321s, 2007.

ReferenceCitation: van Herpen CM, Mauer ME, Mesia R, Degardin M, Jelic S, Coens C, Betka J, Bernier J, Remenar E, Stewart JS, Preiss JH, van den Weyngaert D, Bottomley A, Vermorken JB; EORTC Head and Neck Group. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer. 2010 Oct 12;103(8):1173-81. doi: 10.1038/sj.bjc.6605860. Epub 2010 Sep 14.

ReferenceCitation: Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704.

ReferenceCitation: Bernier J, Coens C, Remenar E, et al.: Impact on quality of life (QoL) of the addition of docetaxel (T) to neoadjuvant cisplatin plus 5-fluorouracil treatment in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN): EORTC study 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5522, 285s, 2006.

ReferenceCitation: Remenar E, Van Herpen C, Lluch JG, et al.: A randomized phase III multicenter trial of neoadjuvant docetaxel plus cisplatin and 5-fluorouracil (TPF) versus neoadjuvant PF in patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN). Final analysis of EORTC 24971. [Abstract] J Clin Oncol 24 (Suppl 18): A-5516, 2006.

ReferenceCitation: Vermorken JB, Remenar E, Van Herpen C, et al.: Standard cisplatin/infusional 5-fluorouracil (PF) vs docetaxel (T) plus PF (TPF) as neoadjuvant chemotherapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN): a phase III trial of the EORTC Head and Neck Cancer Group (EORTC #24971). [Abstract] J Clin Oncol 22 (Suppl 14): A-5508, 490s, 2004.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Poland
Spain
Greece
Austria
Italy
Netherlands
United Kingdom
Switzerland
Hungary
France
Turkey
Belgium
Germany
Slovakia
Former Yugoslavia

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Middlesex Hospital- Meyerstein Institute

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Istanbul University-Institute of Oncology

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Universidad de Santiago - Hospital de Conxo

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Istituti Fisioterapici Ospitalieri - Roma

intervention_type: Radiation


title: INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.

status: Unknown status

enrollment_type: Anticipated

location_country:
Croatia
Italy
Austria
Netherlands
Czech Republic
France
Turkey
Belgium
Germany

location_facility: Universita Degli Studi di Bari Policlinico

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionate


title: RANDOMIZED PHASE III STUDY OF INDUCTION (ICE VS MICE VS DCE) AND INTENSIVE CONSOLIDATION (IDIA VS NOVIA VS DIA) FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA: AML 10 PROTOCOL

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia.

ReferenceCitation: Maurillo L, Buccisano F, Spagnoli A, et al.: In acute myeloid leukemia, the use in induction of standard dose arac is associated with a better quality of response as compared to an induction regimen containing high dose arac. [Abstract] Blood 114 (22): A-1584, 2009.

ReferenceCitation: Oosterveld, M, Suciu S, Muus P, et al.: A new prognostic disease specific model to predict survival after intensive antileukemic treatment for young patients with poor-risk MDS and AML: results of the CRIANT and AML-10 studies conducted by the EORTC/GIMEMA/SAKK/HOVON/EBMT groups. [Abstract] Blood 104 (11): A-2020, 2004.

ReferenceCitation: Mandelli F, Vignetti M, Suciu S, Stasi R, Petti MC, Meloni G, Muus P, Marmont F, Marie JP, Labar B, Thomas X, Di Raimondo F, Willemze R, Liso V, Ferrara F, Baila L, Fazi P, Zittoun R, Amadori S, de Witte T. Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. J Clin Oncol. 2009 Nov 10;27(32):5397-403. doi: 10.1200/JCO.2008.20.6490. Epub 2009 Oct 13. Erratum in: J Clin Oncol. 2010 Mar 10;28(8):1438.

ReferenceCitation: Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Albano F, Lefrère F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Impact of induction regimen and allogeneic hematopoietic cell transplantation on outcome in younger adults with acute myeloid leukemia with a monosomal karyotype. Haematologica. 2019 Jun;104(6):1168-1175. doi: 10.3324/haematol.2018.204826. Epub 2018 Dec 6.

ReferenceCitation: Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Specchia G, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Becker H, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Cytogenetic clonal heterogeneity is not an independent prognosis factor in 15-60-year-old AML patients: results on 1291 patients included in the EORTC/GIMEMA AML-10 and AML-12 trials. Ann Hematol. 2018 Oct;97(10):1785-1795. doi: 10.1007/s00277-018-3396-4. Epub 2018 Jun 20.

location_country:
Croatia
Portugal
Italy
Austria
Netherlands
Czech Republic
Hungary
France
Turkey
Belgium
Germany

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Azienda Ospedale S. Luigi - Universita Di Torino

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionale

location_facility: Policlinico P. Giaccone - Universita Di Palermo

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Universita Degli Studi di Firenze - Policlin. di Careggi

location_facility: Azienda Ospedaliera Ospedale E. Mortelli

intervention_type: Biological


title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN

summary: The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Calliditas Therapeutics Suisse SA

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: University Hospitals Dorset NHS Foundation Trust

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Washington University School of Medicine Center for Advanced Medicine

location_facility: Centre de Lutte contre le Cancer - Centre Antoine Lacassagne

location_facility: MultiCare Institute for Research & Innovation

status_simplified: Ongoing


title: An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

summary: Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

lead_sponsor: Alligator Bioscience AB

location_country: France Spain Belgium

location_facility: Hospital Universitario Vall d'Hebron, Barcelona, Spain

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque,

location_facility: Hospital Universitario Ramon y Cajal, Madrid, Spain

location_facility: Hospital Universitario Virgen del Rocio, Sevilla, Spain

location_facility: Hospital Universitario Miguel Servet, Zaragoza, Spain

location_facility: Hospital Universitario La Paz, Madrid, Spain


title: A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Lambertini M, Ameye L, Hamy AS, Zingarello A, Poorvu PD, Carrasco E, Grinshpun A, Han S, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Cortesi L, Senechal C, Miolo G, Pogoda K, Pérez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Villarreal-Garza C, Dieci MV, Clatot F, Berlière M, Graffeo R, Teixeira L, Córdoba O, Sonnenblick A, Luna Pais H, Ignatiadis M, Paesmans M, Partridge AH, Caron O, Saule C, Del Mastro L, Peccatori FA, Azim HA Jr. Pregnancy After Breast Cancer in Patients With Germline BRCA Mutations. J Clin Oncol. 2020 Sep 10;38(26):3012-3023. doi: 10.1200/JCO.19.02399. Epub 2020 Jul 16.

ipd_sharing_description: Undecided

lead_sponsor: Jules Bordet Institute

location_country:
Poland
Brazil
Portugal
Spain
Italy
Mexico
Switzerland
France
United States
Israel
Belgium

location_facility: Azienda Ospedaliera "Papa Giovanni XXIII"

location_facility: Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon

location_facility: Oncology Institute of Southern Switzerland

location_facility: INCLIVA, University Hospital of Valencia

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Sharett Institute of Oncology - Hadassah Hebrew University Medical Center

location_facility: Policlinico San Martino - IRCCS per l'Oncologia

location_facility: Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia

intervention_type: Other


title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

acronym: CYPIDES

summary: The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
United States
United Kingdom
France

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: The Rutherford Cancer Centre, North West

location_facility: University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

location_facility: The Rutherford Cancer Centre, North East


title: A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

summary: This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

ipd_sharing: Yes

ipd_sharing_description: relevant patient listing data of de-identified patients may be reviewed

lead_sponsor: Mundipharma Research Limited

location_country:
Spain
Italy
Netherlands
Switzerland
United States
France
Germany

location_facility: University Hospital of Ulm, Department of Internal Medicine III

location_facility: National Cancer Institute, Fondazione 'G. Pascale'

location_facility: CHU ESTAING Service de thérapie Cellulaire et hématologique Clinique

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Institute of Hematology "L. A. Seràgnoli", University of Bologna

location_facility: Institut Català d'Oncologia de Barcelona


title: Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

acronym: ACTIVATE-CF

summary: Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.

ReferenceCitation: Hebestreit H, Lands LC, Alarie N, Schaeff J, Karila C, Orenstein DM, Urquhart DS, Hulzebos EHJ, Stein L, Schindler C, Kriemler S, Radtke T; ACTIVATE-CF Study Working Group. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol. BMC Pulm Med. 2018 Feb 8;18(1):31. doi: 10.1186/s12890-018-0596-6.

lead_sponsor: Wuerzburg University Hospital

location_country:
United Kingdom
Austria
Netherlands
Canada
Switzerland
United States
France
Germany

location_facility: Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,

location_facility: Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum

location_facility: Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene

location_facility: Praxis für Lungen- und Bronchialheilkunde

location_facility: UniversitätsSpital, Klinik für Pneumologie

location_facility: Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires

location_facility: Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University

location_facility: Christiane Herzog CF-Zentrum, Goethe Universität

location_facility: Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose

location_facility: Hôpital Necker, Service : Pneumologie et allergologie pédiatriques

location_facility: Klinik für Kinder- und Jugendmedizin / Universitätsklinikum

location_facility: Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq

location_facility: Montreal Children's Hospital, McGill University Health Centre - Glen Site

location_facility: Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen

location_facility: Hôpital Maison Blanche, Service : Maladies respiratoires

location_facility: CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held

location_facility: CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie

location_facility: QuartierBleu, Praxis für Pneumologie am Lindenhofspital

location_facility: Hôpital Renée Sabran, Service : Maladies respiratoires

location_facility: University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital

location_facility: Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques

intervention_type: Behavioral

lead_sponsor_type: academique


status: Terminated

acronym: MYRALL

title: Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

lead_sponsor: Sanofi

source: euctr

ReferenceCitation: Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20. Erratum in: Clin Cancer Res. 2013 Jun 1;19(11):3108.

location_country:
United States
France

location_facility:
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 840004
Investigational Site Number 250002
Investigational Site Number 840006
Investigational Site Number 250005
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 250006
Investigational Site Number 250001
Investigational Site Number 250008

summary:
Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

Response duration
Progression Free Survival
Minimal residual disease
Safety
Pharmacokinetics


intervention_type: Dietary Supplement

title: Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer

lead_sponsor: Acrotech Biopharma Inc.

location_country:
Hungary
United States
France
Czechia

location_facility: University of Debrecen Medical and Health Science Center

location_facility: Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)

location_facility: Fakultní nemocnice Královské Vinohrady - FNKV

location_facility: Centre Régional de Lutte Contre le Cancer Alexis Vautrin

summary: The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.


title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

summary: The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

time_perspective: Prospective

ReferenceCitation: Gerckens U, Tamburino C, Bleiziffer S, Bosmans J, Wenaweser P, Brecker S, Guo J, Linke A. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. 2017 Sep 21;38(36):2729-2738. doi: 10.1093/eurheartj/ehx295.

ReferenceCitation: Bleiziffer S, Bosmans J, Brecker S, Gerckens U, Wenaweser P, Tamburino C, Linke A; ADVANCE Study Investigators. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol. 2017 Oct;106(10):784-795. doi: 10.1007/s00392-017-1120-3. Epub 2017 May 8. Erratum in: Clin Res Cardiol. 2017 Jul 4;:.

ReferenceCitation: Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.

ReferenceCitation: Barbanti M, Schiltgen M, Verdoliva S, Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Gulino S, Tamburino C, Linke A; ADVANCE Study Investigators. Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study). Am J Cardiol. 2016 Mar 1;117(5):820-7. doi: 10.1016/j.amjcard.2015.11.066. Epub 2015 Dec 13.

ReferenceCitation: Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Tamburino C, Linke A; ADVANCE Study Investigators. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients. J Am Coll Cardiol. 2015 Jul 21;66(3):209-217. doi: 10.1016/j.jacc.2015.05.025.

lead_sponsor: Medtronic Bakken Research Center

location_country:
Denmark
Belgium
Portugal
United Kingdom
Greece
Italy
Netherlands
Switzerland
France
Israel
Colombia
Germany

location_facility: Policlinico Vittorio Emanuele, P.O. Ferrarotto

location_facility: Azienda Ospedaliere Spedali Civili di Brescia

intervention_type: Device


title: Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)

ReferenceCitation: Diéras V, Bonnefoi H, Alba E, Awada A, Coudert B, Pivot X, Gligorov J, Jager A, Zambelli S, Lindeman GJ, Charpentier E, Emmons GT, Garcia-Ribas I, Paridaens R, Verweij J. Iniparib administered weekly or twice-weekly in combination with gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer: a phase II randomized open-label study with pharmacokinetics. Breast Cancer Res Treat. 2019 Sep;177(2):383-393. doi: 10.1007/s10549-019-05305-w. Epub 2019 Jun 6.

location_country: Spain Italy Australia France Belgium Netherlands

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 724001

summary:
Primary Objective:

To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC).

Secondary Objectives:

To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks;
To assess Progression-free survival (PFS) and the overall survival (OS);
To assess the safety profile of each schedule of iniparib;
To assess the biological activity in tumor tissue (substudy);
To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);
To characterize molecular and biological profile of tumors (substudy);
To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).


title: Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.

ReferenceCitation: Garufi C, Focan C, Tumolo S, et al.: Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: results from randomized EORTC 05011 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2566, 2007.

location_country: France Italy Portugal Belgium

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Azienda Ospedale S. Luigi at University of Torino

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola


title: An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies

summary:
The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).

lead_sponsor: Bayer

location_facility:
Vanderbilt University Medical Center
Memorial Sloan-Kettering Cancer Center
Montefiore Medical Center
Thomas Jefferson University
Institut Gustave Roussy


title: Open-Label, Exploratory Study to Evaluate the Effects of QR-010 on Nasal Potential Difference in Subjects With CF With the ΔF508 CFTR Mutation

summary: Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).

ReferenceCitation: Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. Review.

lead_sponsor: ProQR Therapeutics

location_country:
United States
France
Belgium

location_facility: Cincinnati Childrens Hospital Medical Center


title: A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies

summary: This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Canada
France

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Princess Margaret Hospital, Medical Oncology & Haematology

location_facility: Cancer Therapy & Research Ctr; Dept Institute for Drug Development


summary: This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.

time_perspective: Cross-Sectional

ReferenceCitation: Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.

lead_sponsor: Allergan

location_country:
Brazil
Australia
Canada
United States
France


title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

summary: To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

lead_sponsor: Merrimack Pharmaceuticals


title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms

acronym: STAT

summary: The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2.

ReferenceCitation: Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

location_facility: CHRU de Brest (Brest University Hospital)

location_facility: Queen Elizabeth II Health Sciences Centre


title: A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

summary: The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.

ReferenceCitation: Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9.

lead_sponsor: Puma Biotechnology, Inc.

location_facility:
Dana Farber Cancer Institute
Institut Gustave Roussy
Beth Israel Deaconess Medical Center
Massachusetts General Hospital


title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)

summary: The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.

lead_sponsor: Eisai Inc.


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of Cetrelimab (JNJ 63723283), an Anti-PD-1 Monoclonal Antibody, in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

summary: The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.

primary_purpose: Basic Science

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country: Poland Spain France Belgium Germany

location_facility: PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.


title: Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder

acronym: RECONNECT

summary: This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

ReferenceCitation: Christensen MC, Schmidt S, Grande I. Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study. J Psychopharmacol. 2022 May;36(5):566-577. doi: 10.1177/02698811221090627. Epub 2022 May 2.

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Spain
Italy
Estonia
Korea, Republic of
France

location_facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. (PL0003)

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej Mentis (PL0004)

location_facility: Chonnam National University Hospital (KR0003)

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. (PL0007)

location_facility: Cabinet du Docteur Karim Boutayeb (FR0001)

location_facility: Inje University Ilsan Paik Hospital (KR0002)

location_facility: Cabinet du Docteur Patrick Bourgoin (FR0002)

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0001)

location_facility: Instituto Internacional de Neurociencias Aplicadas (ES0001)

location_facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk (PL0009)

location_facility: Centrum Medyczne Luxmed Sp.Z O.O. (PL0006)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0003)


title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.

lead_sponsor: Incyte Biosciences International Sàrl

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Belgium
Germany

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Princess Maxima Center For Pediatric Oncology

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Alder Hey Childrens Nhs Foundation Trust

location_facility: Royal Hospital For Sick Children Yorkhill Glasgow

location_facility: L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola ? Malpighi

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori


title: A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)

summary: This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks [q4w] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
France
Germany


title: A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Loebinger MR, Polverino E, Chalmers JD, Tiddens HAWM, Goossens H, Tunney M, Ringshausen FC, Hill AT, Pathan R, Angyalosi G, Blasi F, Elborn SJ, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. Eur Respir J. 2021 Jan 5;57(1). pii: 2001451. doi: 10.1183/13993003.01451-2020. Print 2021 Jan.

ReferenceCitation: Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

summary: The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.


title: A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min

summary: The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Ireland
Spain
France
Belgium


title: A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients.

summary:
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane.

Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.

ReferenceCitation: Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spöttl G, Rank P, Knösel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nölting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

location_country:
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Hungary
United States
France
Germany

location_facility: Memorial Sloan Kettering Cancer Center SC - BYL719Z2102


title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

acronym: TRANSFORM

summary: To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hübner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

lead_sponsor: Pulmonx Corporation

location_country:
United Kingdom
Netherlands
Sweden
France
Belgium
Germany

location_facility: West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Thoraxklinik am Universitäts Klinikum Heidelberg

location_facility: The Royal Brompton Hospital & Harefield NHS Foundation Trust


title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

ReferenceCitation: Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefèvre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.

ReferenceCitation: Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.

lead_sponsor: Edwards Lifesciences

location_country:
United Kingdom
Italy
Canada
France
Germany

location_facility: Laval, Institut universitaire de cardiologie et de pneumologie de Quebec


title: Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries

acronym: BIPAX

summary: The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

lead_sponsor: MINVASYS

location_country: Poland Brazil Spain Italy France Netherlands Bulgaria

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Karol Marcinkowski University of Medical Sciences


title: Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)

acronym: POINT X

summary: This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

ReferenceCitation: Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.

lead_sponsor: Pfizer

location_country:
Denmark
Spain
Italy
United Kingdom
Sweden
Hungary
France
Germany


title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

summary: The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.

lead_sponsor: Shire

location_country:
Spain
Italy
Greece
United Kingdom
Switzerland
France
Germany
Czechia

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Servicio de Transfusión, Hospital Universitario Niño Jesús

location_facility: Paediatric Clinic University Hospital Olomouc

location_facility: Department Haematology, Hospital Ramon y Caja

location_facility: Department of Oncology, Pausilipon Hospital, AORN Santobono

location_facility: Hospital Universitario Virgen de la Arrixac

location_facility: Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique

location_facility: Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin

location_facility: Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital

location_facility: Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari

location_facility: Jefe de Servicio Oncología Y Hematología Pediátricas

location_facility: Complexo Hospitalario Universitario, Santiago

location_facility: Zentrum für Kinder- und Jugendmedizin Klinik II / III

location_facility: Children's Clinic, Royal Berkshire Hospital

location_facility: Paediatric Oncology Unit, Hopital Cote De Nacre

location_facility: Centre Hospitalier Lyon Sud - service Hématologie

location_facility: Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo

location_facility: Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona

location_facility: Department of Cellular Biotechnologies and Hematology. Sapienza University

location_facility: Hamatology Unit. Paediatric Department. University of Torino

location_facility: Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo

location_facility: Clinic of Paediatric haematology and oncology University Hospital Motol

location_facility: Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau


title: A Randomised, Double-blind, Parallel-Group, Fixed Dose Study Exploring the Efficacy and Safety of Lu AE58054 as Augmentation Therapy to Risperidone in Patients With Schizophrenia

location_country:
Poland
Taiwan
Hong Kong
Italy
Thailand
France
Belgium
Germany

summary: The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.


title: Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

summary: The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schöffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

ReferenceCitation: Sleijfer S, Gorlia T, Lamers C, Burger H, Blay JY, Le Cesne A, Scurr M, Collin F, Pandite L, Marreaud S, Hohenberger P. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study. Br J Cancer. 2012 Aug 7;107(4):639-45. doi: 10.1038/bjc.2012.328. Epub 2012 Jul 17.

ReferenceCitation: Kasper B, Sleijfer S, Litière S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Hungary
France
Belgium
Netherlands


title: Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

summary:
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

ReferenceCitation: Raymond E, Brandes AA, Dittrich C, Fumoleau P, Coudert B, Clement PM, Frenay M, Rampling R, Stupp R, Kros JM, Heinrich MC, Gorlia T, Lacombe D, van den Bent MJ; European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008 Oct 1;26(28):4659-65. doi: 10.1200/JCO.2008.16.9235.

ReferenceCitation: Raymond E, Brandes A, Van Oosterom A, et al.: Multicentre phase II study of imatinib mesylate in patients with recurrent glioblastoma: an EORTC: NDDG/BTG Intergroup study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1501, 2004.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
United Kingdom
Italy
Austria
Switzerland
France
Belgium
Netherlands

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center


title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Sweden
France
Germany

location_facility: Hopital Necker Enfants Malades, Service d"Hematologie

location_facility: Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas

location_facility: Royal Free Hospital, Dept. of Haematological Oncology

location_facility: Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie

location_facility: Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

location_facility: Uniklinik Mainz, III. Medizinische Klinik

location_facility: Klinikum der Stadt, Medizinische Klinik A

location_facility: LMU Munchen, Hamatopoetische Zell - Transplantation

location_facility: Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera

location_facility: Johann Wolfgang Goethe Universitat, Medizinische Klinik III

location_facility: Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

location_facility: Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

location_facility: Hopital Henri Mondor, Dervice d'Hematologie Clinique

location_facility: Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas

location_facility: Institute of Haematology and Blood Transfusion


title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

ReferenceCitation: Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. Epub 2006 May 6.

ReferenceCitation: Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdière M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.

location_facility: Hopital Henri Mondor, Service d'Hematologie Clinique

location_facility: Hopital Necker Enfants Malades, Service d'Hematologie

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas

location_facility: Hospital Clinic I provencial, Servicio Enfermadades Infecciosas


title: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

summary: The purpose of this study is to assess the anti-tumor activity of amivantamab subcutaneous administered as a Co-Formulation (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) (Cohorts 1, 2, and 3) in combination treatment and to characterize the safety of amivantamab SC-CF (Cohort 4).

study_start_date_type: Anticipated

status: Not yet recruiting

location_country:
Brazil
Spain
Italy
United Kingdom
Korea, Republic of
United States
France
China
Israel
Malaysia
Japan
Germany

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Tianjin Medical University General Hospital

location_facility: General University Hospital of Alicantet

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: The First Affiliated Hospital, Zhejiang University College of Medicine

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Beijing Cancer Hospital of Peking University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Seoul National University Bundang Hospital

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Policlinico Hospital San Martino- IRCCS for Oncology

location_facility: Harbin medical university cancer hospital

location_facility: Azienda Ospedaliera Specialistica dei Colli

location_facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

acronym: METalmark

summary: The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
China
Turkey
Japan
Germany

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Chonnam National University Hwasun Hospital

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Center

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Second Affiliated Hospital, School of Medicine, Zhejiang University

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp. z o.o.

location_facility: Shengjing Hospital of China Medical University

location_facility: The Oncology Institute of Hope and Innovation

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


title: A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept With Proactive Customized Treatment Intervals in Patients ≥50 Years of Age With No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (Wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation With Aflibercept

acronym: XPAND

summary:
Researchers are looking for a better way to treat people who have neovascular (wet) age-related macular degeneration (nAMD or wet AMD). In people with wet AMD, the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in the area of sharpest vision in the eye, called macula. Fluid buildup due to leakage from these vessels can damage the macula, leading to vision problems such as blurring or a blind spot in the central (straight ahead) vision needed for reading or face recognition or car driving. Wet AMD is common in people aged 50 and older.

The study treatment intravitreal aflibercept (also called BAY865321) is injected into the eye. It works by blocking the VEGF protein and thus reduces blood vessel growth. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start and then every 8 weeks or longer. Repeated injections of aflibercept prevent worsening of vision but place a burden on the patient.

Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye.

The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster (timepoint of extension is the same for both treatments arms), compared to standard T&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation.

To answer this, researchers will assess changes in vision called best corrected visual acuity (BCVA) between study start and after 36 weeks. Changes will then be compared between participants whose treatment intervals were extended early and those on standard T&E regimen.

All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks.

Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually. A final phone call is planned 3 days after treatment at the end of study.

During the study, the doctors and their study team will:

check patients' eye health using various eye examination techniques (slit lamp microscopy, OCT, and ophthalmoscopy) that may necessitate eye drops to widen the pupil)
measure patients' eye vision (BCVA)
do physical examinations
check vital signs
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

In addition, participants in the fast extension arm will be provided with a home monitoring OCT device.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
United Kingdom
Spain
Canada
France
Germany

location_facility: Internationale Innovative Ophthalmochirurgie GbR

location_facility: Centre hospitalier Affilie universitaire de Quebec

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Sunnybrook Health Sciences Center Ophthalmology

location_facility: Centre Hospitalier Intercommunal de Creteil - Ophtalmologie

location_facility: CHU Dijon - Hopital General - Ophtalmologie

location_facility: CHU Bordeaux - Hopital Pellegrin - Ophtalmologie

location_facility: Centre d'Ophtalmologie - Paradis-Monticelli

location_facility: St Joseph's Health Care London - Ivey Eye Institute

location_facility: Centre Ophtalmologique Transparence - Tours

location_facility: Hospital Universitario Virgen de la Macarena


title: A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Administered Via Manual Injection Compared With Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

summary: The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Portugal
Australia
Argentina
India
Israel
Turkey
Malaysia
Brazil
Canada
China
Germany
Taiwan
Thailand
Korea, Republic of
France

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: CIMET's Inamdar Multispeciality Hospital

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc

location_facility: Chonnam National University Hwasun Hospital

location_facility: Saroj Gupta Cancer Center & Research Institute

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Fundacao Pio Xii - Hospital De Cancer De Barretos

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Manipal Comprehensive Cancer Centre, Manipal Hospital

location_facility: Narayana Superspeciality Hospital, Howrah

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: National Taiwan University Cancer Center

location_facility: IADT Instituto Argentino de Diagnostico y Tratamiento

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: University of Mississippi Medical Center

location_facility: The First People's Hospital Of Changzhou

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Seoul National University Bundang Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Phramongkutklao Hospital and Medical College

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

acronym: FUZION CD

summary: The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Australia
Israel
Turkey
Sweden
Egypt
Canada
Hungary
Germany
Taiwan
Jordan
Greece
Korea, Republic of
France
Netherlands

location_facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

location_facility: Washington University School of Medicine

location_facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

location_facility: St George's University Hosptial NHS Foundation Trust

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Mersin University Medical Faculty Hospital

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Alberta- Ziedler Ledcor Centre

location_facility: The University of North Carolina at Chapel Hill

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Hepatology and Tropical Medicine Research Institute

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: South Eastern Health and Social Care Trust

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University of Kentucky Chandler Medical Center

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Gastroenterology Research of San Antonio

location_facility: London North West University Healthcare NHS Trust

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Hospital of the University of Occupational and Enviromental Health

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne


title: A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

acronym: REAL 8

summary: The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
United States
Belgium
Japan
South Africa
Poland
Portugal
Slovenia
Austria
India
Israel
Mexico
Malaysia
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Greece
Ireland
Latvia
Finland
Thailand
Korea, Republic of
France
Netherlands


title: A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

summary: This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
United Kingdom
Netherlands
Argentina
Canada
United States
France
China
Belgium
Japan
Germany


title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Docetaxel in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)

summary: The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and in combination with docetaxel, and to determine the recommended Phase 3 dose of bemarituzumab monotherapy and in combination with docetaxel.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Poland
Taiwan
Spain
Korea, Republic of
United States
France
Belgium
Japan

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Instituto Catalan de Oncologia Hospital Duran i Reynals

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Severance Hospital Yonsei University Health System

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: University of California at Irvine Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: Instytut Genetyki i Immunologii GENIM Spzoo

location_facility: Seoul National University Bundang Hospital