title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

lead_sponsor: Ipsen

ReferenceCitation: Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P; CLARINET Investigators. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 Jan 7.

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
Poland
Spain
Italy
United Kingdom
France
United States
Belgium
Slovakia
Czechia

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny

summary: The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).


title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, Miller C, Mortier L, Murrell DF, Hamid O, Quevedo JF, Hou J, McKenna E, Dimier N, Williams S, Schadendorf D, Hauschild A; ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017 May 16;17(1):332. doi: 10.1186/s12885-017-3286-5. Erratum in: BMC Cancer. 2019 Apr 18;19(1):366.

ReferenceCitation: Chang AL, Arron ST, Migden MR, Solomon JA, Yoo S, Day BM, McKenna EF, Sekulic A. Safety and efficacy of vismodegib in patients with basal cell carcinoma nevus syndrome: pooled analysis of two trials. Orphanet J Rare Dis. 2016 Sep 1;11(1):120. doi: 10.1186/s13023-016-0506-z.

ReferenceCitation: Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. doi: 10.1056/NEJMoa1113713.

lead_sponsor: Genentech, Inc.

location_country:
United Kingdom
Australia
United States
France
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

summary:
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

design_allocation: Randomized

lead_sponsor: Jazz Pharmaceuticals

location_country:
Poland
United States
Canada
France

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Maine General Medical Center Harold Alfond Center for Cancer Care

location_facility: Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Service d'Hématologie CHU Toulouse-Hôpital Purpan

location_facility: Vancouver General Hospital/ British Columbia Cancer Agency

location_facility: Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez

location_facility: Service des Maladies du Sang Hopital Haut-Leveque

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika

location_facility: University of Chicago Medical Center Section of Hematology/Oncology

location_facility: Oncology and Hematology at Lehigh Valley

location_facility: Blumenthal Cancer Center/Mecklenburg Medical Group

location_facility: University of Louisville Brown Cancer Center

location_facility: North Shore LIJ Center for Advanced Medicine Monter Cancer Center

location_facility: Cancer Therapy and Research Center at The University of TX Health Science Center

location_facility: Texas Tech University Health Sciences Center


type: Other Identifier

title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

lead_sponsor: NantCell, Inc.

location_country:
Poland
Hong Kong
Spain
Italy
Russian Federation
Hungary
India
United States
France
Singapore

intervention_type: Biological


type: EudraCT Number

title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)

summary:
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

ReferenceCitation: Berger KL, Lagacé L, Triki I, Cartier M, Marquis M, Lawetz C, Bethell R, Scherer J, Kukolj G. Viral resistance in hepatitis C virus genotype 1-infected patients receiving the NS3 protease inhibitor Faldaprevir (BI 201335) in a phase 1b multiple-rising-dose study. Antimicrob Agents Chemother. 2013 Oct;57(10):4928-36. doi: 10.1128/AAC.00822-13. Epub 2013 Jul 22.

ReferenceCitation: Manns MP, Bourlière M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
United States
Spain
France

location_facility: 1220.2.14 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.12 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.17 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.34001 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.11 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.10 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.15 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49006 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49003 Boehringer Ingelheim Investigational Site


title: A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

summary: The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Apr 5. pii: izac061. doi: 10.1093/ibd/izac061. [Epub ahead of print]

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

ReferenceCitation: Sandborn WJ, Panés J, Zhang H, Yu D, Niezychowski W, Su C. Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial. Gastroenterology. 2016 Jan;150(1):96-102. doi: 10.1053/j.gastro.2015.09.001. Epub 2015 Sep 12.

ReferenceCitation: Panés J, Su C, Bushmakin AG, Cappelleri JC, Mamolo C, Healey P. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015 Feb 5;15:14. doi: 10.1186/s12876-015-0239-9.

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Brazil
Spain
Italy
United Kingdom
Mexico
Czech Republic
Sweden
Hungary
France
Chile
Israel
South Africa
Belgium
Netherlands
Slovakia

intervention_type: Other


title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

summary: The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.

ReferenceCitation: Thertulien R, Manikhas GM, Dirix LY, Vermorken JB, Park K, Jain MM, Jiao JJ, Natarajan J, Parekh T, Zannikos P, Staddon AP. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012 Feb;69(2):341-50. doi: 10.1007/s00280-011-1697-6. Epub 2011 Jul 8.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Spain
Russian Federation
Korea, Republic of
India
United States
France
Belgium


title: Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

lead_sponsor: Eisai Inc.

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

location_country:
Poland
United Kingdom
Italy
Australia
United States
France

summary: The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.


acronym: Not available

title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

lead_sponsor: Puma Biotechnology, Inc.

ReferenceCitation: Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Puerto Rico
Mexico
Singapore
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Jordan
Greece
Thailand
Korea, Republic of
France

location_facility: The Center for Cancer and Blood Disorders

location_facility: SIH Oncology Dispensary # 2 Of Department of Public Health

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Ospedale Misericordia e Dolce c/o UO Oncologia Medica

location_facility: Centre Oscar Lambret Departement de senologie

location_facility: Division of Medical Oncology, Department of Medicine

location_facility: Corporacio Sanitaria Parc Tauli Servicio de Oncologia

location_facility: Oca Hospital / Monterrey International Research Center

location_facility: Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: East Texas Medical Center Cancer Institute, Tyler Hematology Oncology

location_facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie

location_facility: Hospital Universitario Miguel Servet Servicio de Oncologia

location_facility: Hospital General Universitario de Alicante Servicio de Oncologia

location_facility: Hospital Mutua de Terrassa Servicio de Oncologia

location_facility: Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: St. Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: Cancer Care Network of South Texas-HOAST

location_facility: Centro Hospitalario de Jaen Servicio de Oncologia

location_facility: Institut Gustave ROUSSY Service de Pathologie mammaire

location_facility: Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))

location_facility: GVI Oncology Trial Unit Room 110 Panorama Medical Centre

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: Hospital San Pedro de Alcantara Servicio de Oncologia

location_facility: Centro Oncologico M.D. Anderson Internacional

location_facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology

location_facility: Hospital Provincial (Reina Sofia) Servicio de Oncologia

location_facility: Instituto Valenciano de Oncologia Servicio de Oncologia

location_facility: Allegheny General Hospital Allegheny Cancer Center

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy

location_facility: Owsley Brown Frazier Cancer Center (OBFCC)

location_facility: Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii

location_facility: Abteilung fuer Onkologie Departement für Innere

location_facility: Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Hospital Gregorio Marañon Servicio de Oncologia

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center

location_facility: Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal

location_facility: Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Hospital Germans Trias i Pujol Servicio de Oncologia

location_facility: SIH Leningrad Regional Oncology Dispensary

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: MetroHealth Medical Center, Cancer Care Center

location_facility: Institut Jules Bordet Unite du Chimiotherapie

location_facility: Hospital Universitario Dr. Josep Trueta Servicio de Oncologia

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia

location_facility: Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp

location_facility: University of Tennessee Cancer Institute

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: University of Oklahoma Health Sciences Center Dept. of Hematology Oncology

location_facility: Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie

location_facility: Russian Oncology Research Centre of RAMS

location_facility: Thompson Cancer Survival Center Thompson Oncology Group

location_facility: The Royal Marsden NHS Foundation Trust & Institute of Cancer Research

location_facility: Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie

location_facility: Fakultni nemocnice Olomouc Klinika onkologie

location_facility: Institute for Oncology Department for Medical Oncology

location_facility: CHU de Poitiers Service d'oncologie medicale

location_facility: Medical Oncology Royal Adelaide Hospital

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli

location_facility: Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia

location_facility: Scientific Research Institute of Oncology N.N. Petrov

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly

summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

summary:
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Brazil
Romania
Serbia
Italy
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
China
Turkey
Mexico
Japan
Germany
Bulgaria

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

summary: This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.

lead_sponsor: Novartis

location_country:
Poland
Taiwan
Spain
Greece
Italy
Australia
United Kingdom
Canada
Thailand
France
India
Germany

location_facility:
Novartis Investigative Site
Novartis Investigative site


title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

summary: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

ReferenceCitation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

ReferenceCitation: Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.

ReferenceCitation: Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8.

ReferenceCitation: Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1.

lead_sponsor: AstraZeneca

location_country:
Poland
United Kingdom
Russian Federation
Canada
Hungary
India
United States
France
South Africa
Mexico

location_facility: Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.


title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.

ReferenceCitation: Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31. Erratum in: Lancet Oncol. 2015 Apr;16(4):e158.

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.

ReferenceCitation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583. Review.

ipd_sharing: Yes

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.

location_country:
Poland
Romania
Spain
United Kingdom
Austria
Australia
Estonia
Canada
Netherlands
Russian Federation
Ukraine
United States
France
Israel
Belgium
Germany
Czechia

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

summary: This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Canada
Guatemala
Puerto Rico
France
United States
Costa Rica
Mexico
Germany


status: Terminated

title: A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

lead_sponsor: Translational Research in Oncology

location_country:
Spain
Ireland
United Kingdom
Canada
United States
France
Israel
Germany

location_facility: Wake Forest University Baptist Medical Center

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Hospital Universitario Virgen Macarena de Sevilla

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Central Coast Medical Oncology Corporation

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Winship Cancer Institute Emory University School of Medicine

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Centre Hospitalier Départemental Les Oudairies

summary: This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

status_simplified: Unknown


title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

summary: Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Cosgrove DO, Berg WA, Doré CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

ReferenceCitation: Berg WA, Cosgrove DO, Doré CJ, Schäfer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.

lead_sponsor: SuperSonic Imagine

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Yale Medical Center, Department of Diagnostic Radiology

location_facility: University of Southern California - LAC+USC Medical Center, OPD Rm 3P61

location_facility: Thomas Jefferson Medical Center, Department of Radiology

location_facility: Northwestern Memorial Hospital, Dept. of Radiology


title: A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

summary: The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

ReferenceCitation: Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.

lead_sponsor: Centocor Ortho Biotech Services, L.L.C.

location_country:
Spain
United Kingdom
Austria
Netherlands
Finland
Canada
United States
France
Israel
Germany


acronym: PROGRESS

title: A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

lead_sponsor: Abbott

ReferenceCitation: Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/AID.2011.0275. Epub 2012 Aug 3.

ReferenceCitation: Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.

location_country:
Poland
Spain
Italy
Canada
Puerto Rico
United States
France

location_facility:
Site Reference ID/Investigator# 8431
Site Reference ID/Investigator# 8052
Site Reference ID/Investigator# 8402
Site Reference ID/Investigator# 7959
Site Reference ID/Investigator# 7690
Site Reference ID/Investigator# 7698
Site Reference ID/Investigator# 8396
Site Reference ID/Investigator# 7960
Site Reference ID/Investigator# 7689
Site Reference ID/Investigator# 7692
Site Reference ID/Investigator# 7693
Site Reference ID/Investigator# 7821
Site Reference ID/Investigator# 8424
Site Reference ID/Investigator# 8393
Site Reference ID/Investigator# 8433
Site Reference ID/Investigator# 8063
Site Reference ID/Investigator# 7691
Site Reference ID/Investigator# 11102
Site Reference ID/Investigator# 7700
Site Reference ID/Investigator# 8429
Site Reference ID/Investigator# 8395
Site Reference ID/Investigator# 8403
Site Reference ID/Investigator# 7695
Site Reference ID/Investigator# 8099
Site Reference ID/Investigator# 8426
Site Reference ID/Investigator# 8432
Site Reference ID/Investigator# 7831
Site Reference ID/Investigator# 8425
Site Reference ID/Investigator# 7789
Site Reference ID/Investigator# 11461
Site Reference ID/Investigator# 8221
Site Reference ID/Investigator# 8050
Site Reference ID/Investigator# 7697
Site Reference ID/Investigator# 7713
Site Reference ID/Investigator# 8051
Site Reference ID/Investigator# 8394
Site Reference ID/Investigator# 7963

summary: The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

acronym: ASPIRE

summary:
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia

The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

ReferenceCitation: Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. doi: 10.3371/CSRP.KASA.022015. Epub 2015 Feb 24.

ReferenceCitation: Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Croatia
Poland
Italy
Austria
Estonia
Thailand
Hungary
Korea, Republic of
United States
Chile
France
Puerto Rico
Belgium
South Africa
Bulgaria


title: A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

ReferenceCitation: Awada A, Dirix L, Manso Sanchez L, Xu B, Luu T, Diéras V, Hershman DL, Agrapart V, Ananthakrishnan R, Staroslawska E. Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy. Ann Oncol. 2013 Jan;24(1):109-16. doi: 10.1093/annonc/mds284. Epub 2012 Sep 11.

location_country:
Poland
Taiwan
Hong Kong
Spain
United Kingdom
Sweden
United States
France
China
Belgium
Netherlands

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Martini Ziekenhuis / Afdeling Interne Geneeskunde

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital 12 de Octubre, Servicio de Oncologia Medica

location_facility: Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center

location_facility: St.-Augustinus Hospital Oncology Department

location_facility: Hematology Oncology Associates of Rockland

location_facility: Onkologiska Kliniken Universitetssjukhuset i Lund

location_facility: Hospital Arnau de Vilanova, Servicio de Oncologia Medica

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital

location_facility: Institut Curie, Département d'Oncologie Médicale

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Centrum Onkologii Ziemii Lubelskiej, Oddział Chemioterapii

summary:
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.


title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

lead_sponsor: UCB Pharma

ReferenceCitation: Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.

location_country:
Spain
Italy
Hungary
United States
France
Germany

summary: Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.


acronym: PROCLAIM

intervention_type: Radiation

title: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

ReferenceCitation: Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.

ReferenceCitation: Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.

location_country:
Taiwan
Brazil
Portugal
Spain
Greece
Ireland
Australia
Netherlands
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
China
India
Belgium
Turkey
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

summary: This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.


title: An Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1β Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

ReferenceCitation: Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Hawkins PN, Tran TA, Bader-Meunier B, Hoyer J, Gattorno M, Gul A, Smith J, Leslie KS, Jiménez S, Morell-Dubois S, Davis N, Patel N, Widmer A, Preiss R, Lachmann HJ. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011 Dec;70(12):2095-102. doi: 10.1136/ard.2011.152728. Epub 2011 Aug 21.

location_country:
Spain
Italy
United Kingdom
India
United States
France
Turkey
Belgium
Germany

location_facility: Rush-Presbyterian St. Lukes Medical Center

summary:
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease.

The duration of this study was 6 months with a maximum duration of 2 years


title: A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

lead_sponsor: AbbVie (prior sponsor, Abbott)

ReferenceCitation: Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243.

ReferenceCitation: Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.

location_country:
Denmark
Spain
Greece
Austria
Italy
Netherlands
Finland
Canada
Switzerland
United Kingdom
Sweden
France
Belgium
Germany

location_facility:
Site Reference ID/Investigator# 8019
Site Reference ID/Investigator# 10702
Site Reference ID/Investigator# 11841
Site Reference ID/Investigator# 8035
Site Reference ID/Investigator# 13461
Site Reference ID/Investigator# 9583
Site Reference ID/Investigator# 8362
Site Reference ID/Investigator# 11661
Site Reference ID/Investigator# 12763
Site Reference ID/Investigator# 11864
Site Reference ID/Investigator# 11701
Site Reference ID/Investigator# 8034
Site Reference ID/Investigator# 8020
Site Reference ID/Investigator# 13163
Site Reference ID/Investigator# 8363
Site Reference ID/Investigator# 13223
Site Reference ID/Investigator# 8185
Site Reference ID/Investigator# 13481
Site Reference ID/Investigator# 8025
Site Reference ID/Investigator# 11161
Site Reference ID/Investigator# 10203
Site Reference ID/Investigator# 11381
Site Reference ID/Investigator# 8032
Site Reference ID/Investigator# 13161
Site Reference ID/Investigator# 13422
Site Reference ID/Investigator# 8027
Site Reference ID/Investigator# 9904
Site Reference ID/Investigator# 13104
Site Reference ID/Investigator# 13462
Site Reference ID/Investigator# 11001
Site Reference ID/Investigator# 8026
Site Reference ID/Investigator# 8024
Site Reference ID/Investigator# 12381
Site Reference ID/Investigator# 8033
Site Reference ID/Investigator# 8551
Site Reference ID/Investigator# 8021
Site Reference ID/Investigator# 12401
Site Reference ID/Investigator# 13221
Site Reference ID/Investigator# 10963
Site Reference ID/Investigator# 8030
Site Reference ID/Investigator# 11504
Site Reference ID/Investigator# 8022
Site Reference ID/Investigator# 8023

summary: This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.


title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

lead_sponsor: Genentech, Inc.

ReferenceCitation: Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.

location_country:
Denmark
Romania
Serbia
Spain
Italy
Russian Federation
Mexico
United Kingdom
Canada
Switzerland
Ukraine
United States
France
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Nemocnica s Poliklinikou Spisska Nova Ves, a.s.

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Legacy Health System; Clinical Research & Tech Ctr

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Fakultna Nemocnica Nitra; Neurologicka Klinika

location_facility: Shat of Cardiovascular Diseases; Clinic of Neurology

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Spitalul Clinic Colentina; Clinica de Neurologie

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie

location_facility: Fletcher Allen Health Care/University of Vermont

location_facility: Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU

location_facility: LLC Research Medical Complex Vashe Zdorovie

location_facility: Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology

location_facility: Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu

location_facility: UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY

location_facility: McGill University; Montreal Neurological Institute; Neurological and Psychiatric

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY

location_facility: Ohio State University Med Ctr; MS Center

location_facility: University of Virginia - Fontain Research Park

location_facility: Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla

location_facility: Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika

location_facility: MRC for Oncology and Neurology; Neurology

location_facility: Suny At Stony Brook; Department Of Neurology

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Uni of British Columbia Hospital; Ms Clinical Research Group

location_facility: Hospital Universitario La Fe; Unidad de Esclerosis Multiple

location_facility: Asklepios Klinik Nord-Heidberg; Neurologie

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum

location_facility: CHU De Caen; Service De Neurologie Dejerine

location_facility: Clinical Center Nis; Clinic for Mental Health

location_facility: Shepherd Center; Multiple Sclerosis Center

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Clinical Center of Serbia; Institute of Neurology

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: East Bay Physicians Med Group;Sutter East Bay Med Foundation

location_facility: Michigan Institute for Neurological Disorders

location_facility: Dartmouth-Hitchcock Medical Center; Dept of Neurology

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

summary: This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


title: Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

summary: This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

ReferenceCitation: Guja C, Frías JP, Suchower L, Hardy E, Marr G, Sjöström CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum in: Diabetes Ther. 2020 Dec;11(12):3011-3013.

ReferenceCitation: Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

ReferenceCitation: Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.

ReferenceCitation: Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, González JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Poland
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Hungary
Germany
Korea, Republic of
France

location_facility:
Research SIte
Research Site


title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

acronym: REFINE-ICD

summary: This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

status: Unknown status

ReferenceCitation: Perkiömäki J, Exner DV, Piira OP, Kavanagh K, Lepojärvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15.

ipd_sharing: Undecided

ipd_sharing_description: uncertain

lead_sponsor: University of Calgary

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Finland
Canada
Sweden
Hungary
United States
France
South Africa
Belgium
Norway
Germany
Slovakia

location_facility: Aurora St. Luke's Medical Center/Aurora Cardiovascular Services

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: HUCH Helsinki University Central Hospital

location_facility: Hospital Universitario Clinic de Barcelona

location_facility: Hospital General Universitario de Alicante (HGUA)

location_facility: Associated Cardiovascular Consultants/Lourdes Cardiology Services

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)

location_facility: Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Libin Cardiovascular Institute of Alberta

location_facility: St. Paul's Hospital/Providence Health Care

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Hôpital Guillaume et René Laënnec - CHU de Nantes

lead_sponsor_type: academique


title: A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation

acronym: AVRO

summary: The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

ReferenceCitation: Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.

lead_sponsor: Advanz Pharma

location_country:
Denmark
Poland
Serbia
Latvia
Estonia
Australia
Canada
Czech Republic
Finland
Lithuania
Netherlands
Sweden
Ukraine
France
Germany
Slovakia

location_facility: Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin

location_facility: Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology

location_facility: Herzzentrum Brandenburg in Bernau Innere Medizin

location_facility: East Tallinn Central Hospital-Clinic of Cardiology

location_facility: City Clinical Hospital #9 Dept of Arrhythmia

location_facility: McGill University Health Center The Montreal General Hospital

location_facility: Oblastni nemocnice Pribram Interni Oddeleni

location_facility: Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie

location_facility: Slovensky ustav srdcovych a cevnych chorob

location_facility: Ambulantes Herzzentrum Kassel Innere Medizin

location_facility: Gentofte Amtssygehus Kardiologisk afdeling

location_facility: Interna klinika FN Trnava, Fakultna nemocnica Trnava

location_facility: Launceston General Hospital Cardiac Research Unit

location_facility: Clinical Center of Serbia, Institute of CV Diseases

location_facility: Okregowy Szpital Kolejowy w Lublinie Samodzielny

location_facility: Klinikum der Universität Köln, Medizinische Klinik III

location_facility: Latvian Center of Cardiology, P. Stradins Clinical University Hospital

location_facility: Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur

location_facility: Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction

location_facility: WCN - Department of Cardiology Rijnstate Ziekenhuls

location_facility: N.D. Strazhesko Institute of Cardiology Intensive Care Unit

location_facility: Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika

location_facility: Oulu University Hospital - Dept of Internal Medicine

location_facility: Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

location_facility: Middle Slovak Institute of Cardiovascular Diseases (SUSCCH)

location_facility: City Clinical Hospital #1 Intensive Care Unit

location_facility: Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie

location_facility: Clinical Center Zemun, Dept. of Cardiology

location_facility: Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii

location_facility: Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie

location_facility: CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie

location_facility: Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny

location_facility: Universitätsklinikum Bonn, Med. Klinik und Poliklinik II

location_facility: Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im.

location_facility: Medizinische Klinik, Klinikum Hannover Nordstadt

location_facility: Centre Hopitalier de L'Universite de Montreal - Hotel Dieu

location_facility: III Klinika Chorob Wewnetrznych i Kardiologii

location_facility: Klinikum Pirna GmbH, Innere Medizin II, Kardiologie

location_facility: Nemocnice Kutna Hora s.r.o. Interni Oddeleni

location_facility: Royal Hobart Hospital Cardiology Research

location_facility: Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie

location_facility: Kiev City Clinical Hospital No 5, Coronary Care Unit

location_facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

location_facility: Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej

location_facility: Kaunas Medical University Hospital - Department of Cardiology

location_facility: Hopital Trousseau - Service de Cardiologie

location_facility: Institute of Treatment and Reahabilitation 'Niska Banja'

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Lugansk First Clinical Multiprofile Hospital #1, Cardiology

location_facility: CHU de Nancy - Hopital Brabois - Service de Cardiologie

location_facility: Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie

location_facility: Ustredni vojenska nemocnice Koronarni jednotka


title: A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET

ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

location_country:
Poland
Spain
Netherlands
United States
France
Belgium
Germany

summary:
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis:

Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
rhabdomyosarcoma
leiomyosarcoma
adipocytic sarcoma
synovial sarcoma.

A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.


acronym: Pediatric trial with Intelence as an Active NNRTI Option (PIANO)

title: A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents

lead_sponsor: Tibotec Pharmaceuticals, Ireland

ReferenceCitation: Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.

location_country:
Brazil
Portugal
Spain
United Kingdom
Argentina
Canada
Thailand
Puerto Rico
United States
France
South Africa
Romania
Netherlands

summary: The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.


title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

summary: A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Faragó G, Haverstock D, Trajanovic M, Sethi S. A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology. Int J Chron Obstruct Pulmon Dis. 2011;6:373-83. doi: 10.2147/COPD.S21071. Epub 2011 Jun 29.

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Haverstock D, Trajanovic M, Sethi S. Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:985-93. doi: 10.2147/COPD.S80926. eCollection 2015.

lead_sponsor: Bayer

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Peru
Belgium
Philippines
South Africa
Hong Kong
Portugal
Australia
Argentina
Indonesia
Mexico
Brazil
Canada
Switzerland
China
Germany
Greece
Ireland
Latvia
Czech Republic
Andorra
Thailand
France
Chile
Colombia
Netherlands
Pakistan


title: A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity

acronym: SONIC

summary: A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Spain
Italy
Russian Federation
Australia
Netherlands
United Kingdom
Hungary
France
Belgium
Germany
Czechia


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Taiwan
Romania
United Kingdom
Austria
Australia
Canada
Lithuania
Ukraine
Sweden
Korea, Republic of
France
Malaysia
Belgium
Philippines
Germany
Bulgaria
Slovakia

summary: This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.


title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients

acronym: DIA-AID

summary: The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

ReferenceCitation: Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Procházka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391. Retraction in: Diabetes Care. 2015 Jan;38(1):178.

RetractionSource: Diabetes Care. 2015 Jan;38(1):178

ReferenceCitation: Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9. Retraction in: Diabetes Care. 2015 Jan;38(1):179.

RetractionSource: Diabetes Care. 2015 Jan;38(1):179

lead_sponsor: Andromeda Biotech Ltd.

location_country:
Spain
Greece
Austria
Italy
United Kingdom
Finland
Czech Republic
France
Israel
South Africa
Germany

location_facility: Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin

location_facility: Hospital Nuestra Señora de La Candelaria

location_facility: Diabetes Centre for Children and Adolescents


title: A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen

summary: The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

lead_sponsor: Pfizer

location_country:
Poland
Spain
Italy
Canada
Korea, Republic of
United States
France
Japan


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

summary: Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

ReferenceCitation: Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.

ReferenceCitation: Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.

ReferenceCitation: Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.

ReferenceCitation: Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.

ipd_sharing: No

lead_sponsor: Theratechnologies

location_country:
Spain
United Kingdom
Canada
United States
France
Belgium

location_facility: University of North Carolina at Chapel Hill

location_facility: Groupe de Recherche en Rhumatologie et maladies osseuses

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Centre Hospitalier Universitaire de Santé de l'Estrie

location_facility: Infectious Disease Research Institute Inc.

location_facility: Indiana University Department of Medicine

location_facility: McMaster University Health Sciences Centre

location_facility: AIDS Community Research Initiative of America


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

ReferenceType: background

ReferenceCitation: Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Russian Federation
Australia
Estonia
Canada
Netherlands
Thailand
United States
Chile
France
Peru
Mexico
South Africa
Germany
Bulgaria
Czechia


acronym: EMERALD 2

title: AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin

lead_sponsor: Affymax

ReferenceCitation: Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.

ReferenceCitation: Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Romania
Germany
Bulgaria

location_facility:
Research Facilities (2)
Research Facility

summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


title: A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

acronym: SCORE

summary: This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

ReferenceCitation: Peterfy C, Emery P, Tak PP, Østergaard M, DiCarlo J, Otsa K, Navarro Sarabia F, Pavelka K, Bagnard MA, Gylvin LH, Bernasconi C, Gabriele A. MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study. Ann Rheum Dis. 2016 Jan;75(1):170-7. doi: 10.1136/annrheumdis-2014-206015. Epub 2014 Oct 29.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Brazil
Serbia
Spain
Greece
Latvia
Estonia
Netherlands
Argentina
Czech Republic
Canada
Lithuania
Russian Federation
Switzerland
France
Turkey
Romania
Norway
Germany


title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

ReferenceCitation: Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

lead_sponsor: Novartis

location_country:
Denmark
Taiwan
Italy
Russian Federation
Finland
Canada
Czech Republic
Hungary
France
India
Peru
Colombia
Iceland
Germany
Slovakia

location_facility:
Novartis Investigator site
Novartis Investigative Site
Novartis Investgative Site
Novartis investigator site
novartis Investigator site
Novartis Investigator Site


title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

ReferenceCitation: Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.

location_country:
Brazil
Spain
Italy
United Kingdom
Australia
Canada
United States
Chile
France
Israel
Germany

summary: Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

summary: PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

ReferenceCitation: MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

location_country:
United Kingdom
Greece
Russian Federation
Australia
Argentina
Canada
Hungary
Korea, Republic of
France
Chile
South Africa
Netherlands
Czechia


title: AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

ReferenceCitation: von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquée L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schütte W, Lorigan P, Reck M, Domine M, Shepherd FA, Li S, Renschler MF. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014 Dec 10;32(35):4012-9. doi: 10.1200/JCO.2013.54.5392. Epub 2014 Nov 10.

lead_sponsor: Celgene

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Hungary
United States
France
Belgium
Germany
Bulgaria
Czechia

location_facility: Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Texas Cancer Center at Medical City (Main)

location_facility: SUNY Upstate Medical University - Regional Oncology Center

location_facility: New South Wales Southern Medical Day Care Centre

location_facility: Universitätsklinikum Essen Innere Klinik und Poliklinik

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau

location_facility: Michigan Hematology & Oncology Institute

location_facility: Comprehensive Care Centers of Nevada (Main)

location_facility: St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie

location_facility: Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

location_facility: Little Rock Hematology Oncology Associates

location_facility: CHU Montpellier - Unité de Cancérologie Thoracique

location_facility: Odense Universitetshospital,Onkologisk afdeling R

location_facility: Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie

location_facility: Hospital General Universitario de Valencia

location_facility: Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej

location_facility: Centre Hospitalier Notre-Dame et Reine Fabiola

location_facility: Fraser Valley Cancer Centre-Surrey Memorial Hospital

location_facility: Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: Országos Korányi Tbc és Pulmonológiai Intézet

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: UZ Brussel, Medical Oncology and Hematology

location_facility: Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg AG

location_facility: Hospital Universitario Virgin de la Victoria

location_facility: University of Colorado Health Science Centre

location_facility: Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: University of Minnesota Medical Center, Cancer Center

location_facility: Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases

location_facility: Fundación Jiménez Díaz. Universidad Autónoma de Madrid

location_facility: Cancer Care Associates of Fresno Medical Group, Inc.

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Alliance Hematology Oncology, P.A. (Main)

location_facility: Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie

location_facility: Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology

location_facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

location_facility: Fakultní Thomayerova nemocnice s poliklinikou

location_facility: Fairfax Northern Virginia Hematology/Oncology

location_facility: Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: The Princess Alexandra Hospital, Dept of Respiratory Medicine

location_facility: Cancer & Hematology Specialists of Chicago (Main)

location_facility: Tulane University Health Sciences Center

location_facility: Zespol nr 1 Szpitala im. St. Leszczynskiego

location_facility: The Sarah Cannon Research Institute/TN Oncology

location_facility: Northwest Cancer Specialists - Vancouver (Main)

location_facility: Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: Rocky Mountain Cancer Center - Midtown (Main)

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

ReferenceCitation: Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.

location_country:
Brazil
Portugal
Spain
United Kingdom
Russian Federation
Australia
Mexico
Canada
Thailand
Puerto Rico
United States
Chile
China
Costa Rica
Belgium
France
Germany
India
Panama
South Africa


title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

summary: The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

ReferenceCitation: McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.

lead_sponsor: Warner Chilcott

location_country:
Poland
Estonia
Argentina
Canada
Hungary
United States
France
Belgium

location_facility:
Research Facility
Research Site


title: A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

summary: The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Italy
Russian Federation
Ukraine
India
United States
France
Germany

location_facility: Southwest Cancer Treatment And Research Center

location_facility: The Angeles Clinic & Research Institute, Inc

location_facility: Birmingham Hematology & Oncology Assoc. Llc

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Cmc-Northeast/ Northeast Oncology Associates

location_facility: Compassionate Cancer Care Medical Group, Inc.