title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

acronym: CRYSTAL

summary:
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.

Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.

ReferenceCitation: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

ReferenceCitation: Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281

ReferenceCitation: Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345

ReferenceCitation: Dercle L, Lu L, Lichtenstein P, Yang H, Wang D, Zhu J, Wu F, Piessevaux H, Schwartz LH, Zhao B. Impact of Variability in Portal Venous Phase Acquisition Timing in Tumor Density Measurement and Treatment Response Assessment: Metastatic Colorectal Cancer as a Paradigm. JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.17.00108.

ReferenceCitation: Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797. Erratum in: JAMA Oncol. 2017 Dec 1;3(12):1742.

ReferenceCitation: Licitra L, Störkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Spain
Italy
United Kingdom
Ukraine
Romania
Belgium
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Sweden
Slovakia
Brazil
Hungary
Germany
Bulgaria
Taiwan
Greece
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility:
Research Sites
Research Site


title: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

summary: Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

status: No longer available

study_type: Expanded Access

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
New Zealand
Canada
United Kingdom
Switzerland
Puerto Rico
United States
France
South Africa
Belgium
Norway
Germany
Czechia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

summary: The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

status: Approved for marketing

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Barrios CH, Herchenhorn D, Chacón M, Cabrera-Galeana P, Sajben P, Zhang K. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma. Onco Targets Ther. 2016 Sep 23;9:5839-5845. eCollection 2016.

ReferenceCitation: Lee SH, Bang YJ, Mainwaring P, Ng C, Chang JW, Kwong P, Li RK, Sriuranpong V, Toh CK, Yuan J, Pitman Lowenthal S, Chung HC. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014 Sep;10(3):237-45. doi: 10.1111/ajco.12163. Epub 2014 Feb 27.

ReferenceCitation: Gore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, Lee SH, Carteni G, Nieto A, Yuan J, Szczylik C. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer. 2011 Feb 1;117(3):501-9. doi: 10.1002/cncr.25452. Epub 2010 Sep 22.

ReferenceCitation: Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schöffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. doi: 10.1016/S1470-2045(09)70162-7. Epub 2009 Jul 15.

lead_sponsor: Pfizer

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Venezuela
United States
Peru
Belgium
Philippines
Romania
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Panama
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Ireland
Ecuador
Czech Republic
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.

summary:
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Portugal
United Kingdom
Greece
Italy
Australia
Netherlands
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: 1st Social Insurance Foundation (IKA) Pentelis

location_facility: McGill University Health Centre, Suite A5-140

location_facility: Centre Hospitalier Universitaire St. Pierre

location_facility: Korgialenio-Benakio-Hellenic Red Cross General Hospital

location_facility: Montreal Chest Institute - McGill University Health Centre

location_facility: Boehringer Ingelheim Investigational Site

location_facility: ifi Institut für interdisziplinäre Infektiologie

location_facility: Canadian Immunodeficiency Research Collaborative Inc.

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

status_simplified: Completed


title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.

status: Unknown status

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Eggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.

ReferenceCitation: Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

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

location_country:
Denmark
Poland
Portugal
Serbia
Spain
Italy
Russian Federation
Estonia
Australia
Finland
Netherlands
Switzerland
United Kingdom
France
Israel
Belgium
Norway
Germany

location_facility: Instituto Portugues de Oncologia Centro do Porto, S. A.

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Royal Free and University College Medical School

location_facility: North-Estonian Regional Hospital Surgical Oncology Centre

location_facility: Ospendale S.M. Annunziata-A.S.DI Florence

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Centre Hospitalier Regional et Universitaire de Lille

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

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Selly Oak Hospital at University Hospital NHS Trust

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

intervention_type: Biological


title: First Line Infusional 5-Fluorouracil, Folinic Acid and Oxaliplatin for Metastatic Colorectal Cancer or Loco-Regional Recurrency - Role of Chronomodulated Delivery Upon Survival - A Multicenter Randomized Phase III Trial

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Efficace F, Innominato PF, Bjarnason G, Coens C, Humblet Y, Tumolo S, Genet D, Tampellini M, Bottomley A, Garufi C, Focan C, Giacchetti S, Lévi F; Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. Validation of patient's self-reported social functioning as an independent prognostic factor for survival in metastatic colorectal cancer patients: results of an international study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2008 Apr 20;26(12):2020-6. doi: 10.1200/JCO.2007.12.3117.

ReferenceCitation: Giacchetti S, Zidani R, Perpoint B, et al.: Phase III trial of 5-fluorouracil (5-FU), folinic acid (FA), with or without oxaliplatin (OXA) in previously untreated patients (pts) with metastatic colorectal cancer (MCC). [Abstract] Proceedings of the American Society of Clinical Oncology 16: A805, 229a, 1997.

ReferenceCitation: Lévi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet. 1997 Sep 6;350(9079):681-6.

ReferenceCitation: Mormont MC, Bleuzen P, Lellouch J, et al.: Prognostic value of circadian rhythm assessment for survival of patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-956, 269a, 1997.

ReferenceCitation: Innominato PF, Giacchetti S, Moreau T, Smaaland R, Focan C, Bjarnason GA, Garufi C, Iacobelli S, Tampellini M, Tumolo S, Carvalho C, Karaboué A, Lévi F; ARTBC International Chronotherapy Group. Prediction of survival by neutropenia according to delivery schedule of oxaliplatin-5-Fluorouracil-leucovorin for metastatic colorectal cancer in a randomized international trial (EORTC 05963). Chronobiol Int. 2011 Aug;28(7):586-600. doi: 10.3109/07420528.2011.597532.

ReferenceCitation: Giacchetti S, Bjarnason G, Garufi C, Genet D, Iacobelli S, Tampellini M, Smaaland R, Focan C, Coudert B, Humblet Y, Canon JL, Adenis A, Lo Re G, Carvalho C, Schueller J, Anciaux N, Lentz MA, Baron B, Gorlia T, Lévi F; European Organisation for Research and Treatment of Cancer Chronotherapy Group. Phase III trial comparing 4-day chronomodulated therapy versus 2-day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Group. J Clin Oncol. 2006 Aug 1;24(22):3562-9.

ReferenceCitation: Garufi C, Bjarnason GA, Giacchetti S, et al.: Independent prognostic value of the rest/activity circadian rhythm on overall survival (OS) in patients (pts) with metastatic colorectal cancer (MCC) receiving first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin: a companion study to EORTC 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3553, 259s, 2005.

ReferenceCitation: Innominato PF, Focan C, Bjarnason GA, et al.: Quality of life (QoL) correlates with the rest/activity circadian rhythm (RAR) in patients (pts) with metastatic colorectal cancer (MCC) on first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin : an international multicenter study (EORTC 05963). [Abstract] J Clin Oncol 23 (Suppl 16): A-8029, 736s, 2005.

ReferenceCitation: Lévi F, Gorlia T, Tubiana N, et al.: Gender as a predictor for optimal dynamic scheduling of oxaliplatin, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Results from EORTC randomized phase III trial 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3587, 267s, 2005.

ReferenceCitation: Giacchetti S, Bjarnason GA, Garufi C, et al.: First line infusion of 5-fluorouracil, leucovorin, oxaliplatin for metastatic colorectal cancer chronomodulated versus conventional delivery. A multicenter randomized trial of the EORTC chronotherapy group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2231, 2002.

location_country: Portugal Greece Austria Italy Canada France Belgium Norway Germany

location_facility: Centre Hospital Regional Universitaire de Limoges

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

location_facility: Sunnybrook and Women's College Health Sciences Centre

location_facility: Azienda Ospedale S. Luigi - Universita Di Torino

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Haukeland Hospital - University of Bergen

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Azienda Ospedaliera "Santa Maria Degli Angeli"

location_facility: Istituti Fisioterapici Ospitalieri - Roma


title: Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.

location_country:
Denmark
Portugal
Spain
Greece
Austria
Italy
Netherlands
United Kingdom
Switzerland
France
Israel
Belgium
Norway
Germany

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Schneider Children's Medical Center of Israel


title: PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.

location_facility: Centro di Riferimento Oncologico - Aviano


title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.


type: EudraCT Number

title: ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

acronym: ROSY-D

summary: The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

study_start_date_type: Actual

status: Enrolling by invitation

study_completion_date_type: Anticipated

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.

lead_sponsor: AstraZeneca

location_country:
Brazil
United Kingdom
Italy
Canada
Thailand
Korea, Republic of
United States
France
Germany
Bulgaria
Czechia


type: Other Identifier

title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

acronym: DUET-UC

summary: The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

status: Recruiting

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Argentina
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Korea, Republic of
France
Chile
Netherlands

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

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: University Hospital Alexandrovska - Clinic of Nephrology

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: Hospital Clinico Regional Dr. Guillermo Grant Benavente

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Hadassah Hebrew University Medical Center

location_facility: Centro de Investigación Clínica Acelerada, SC

location_facility: SER - Serviços Especializados em Reumatologia da Bahia

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

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

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Special hospital for Internal diseases, Oncomed system

location_facility: McGill University - Health Centre - Montreal General Hospital

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: Praxis fur Innere Medizin und Gastroenterologie

location_facility: Complejo Asistencial Hospital Dr. Sótero del Río

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: University North Carolina at Chapel Hill

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: Herlev Hospital, University of Copenhagen

location_facility: South Eastern Health and Social Care Trust

location_facility: Severance Hospital, Yonsei University Health System

location_facility: UW School of Medicine and Public Health - Office of Clinical Trials

location_facility: Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

location_facility: Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj

location_facility: University of Kentucky Chandler Medical Center

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

location_facility: Diagnostic Consultative Center - DCC Sv. Pantaleymon EOOD

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Pracownia Endoskopowa Szpital Zakonu Bonifratrow sw. Jana Bozego w Lodzi sp. z o.o.

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: University Hospitals Case Medical Center

location_facility: Military Medical Academy, Clinic for Psychiatry

location_facility: Centro de Estudios Clínicos e Investigación Médica (CeCim)

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo

location_facility: Siksha O Anusandhan University - Institute of Medical Scienc

location_facility: Gemeinschaftspraxis Mainz Mitte am Gesundheitscentrum Mainz

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: National Hospital Organization Osaka National Hospital

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

location_facility: St George's University Hosptial NHS Foundation Trust

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova

location_facility: Worthwhile Clinical Trials Lakeview Hospital

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Multriprofile Hospital for Active Treatment Hristo Botev

location_facility: National Taiwan University Hospital, Division of Infectious Diseases

location_facility: London Health Sciences Centre - University Campus

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Sotiria General State Hospital of Chest Diseases

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

location_facility: University of California San Diego Health

location_facility: General Hospital of Athens 'G. Gennimatas'

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Gastroenterologische Praxis Balsiger und Seibold

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: The Catholic university of Korea, St. Vincent's Hospital

status_simplified: Ongoing


title: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

summary: The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP), respectively, in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure.

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

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Sweden
Brazil
Canada
China
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Centro de Investigaciones Clinicas-CIC-IESR

location_facility: Daping Hospital Army Characteristic Medical Center

location_facility: Tianjin Medical University General Hospital

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: The First Affiliated hospital of Anliui Medical University

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: Cancer Care Specialists of Central Illinois

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

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

location_facility: Bhaktivedanta Hospital & Research Institute

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

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Kobe City Medical Center General Hospital

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: University of Miami/Sylvester Cancer Center

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Affiliated Hospital of North Sichuan Medical College

location_facility: University of Tennessee Health Sciences Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Multifunctional Hospital for Active Treatment 'Serdika'

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Main Administration for Service to the Diplomatic Corps under the MoFA of the RF

location_facility: Nizhny Novgorod Regional Oncological Dispensary

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

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: ViDia Christliche Kliniken Karlsruhe/St. Vincentius-Kliniken

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

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

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncology Medical Clinics AV Medical group

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Pacific Shores Medical Group in Long Beach

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

location_facility: Pan American Center for Oncology Trials LLC

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliero-Universitaria Di Parma

location_facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Fakultni nemocnice Olomouc - I.P.Pavlova 6

location_facility: IADT Instituto Argentino de Diagnostico y Tratamiento

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Barts Heart Centre, St. Bartholomew's Hospital

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

location_facility: North Shore-Long Island Jewish Health System

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

location_facility: University of Mississippi Medical Center

location_facility: The First People's Hospital Of Changzhou

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: National Hospital Organization Nagoya Medical Center

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

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

location_facility: Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst

location_facility: Pacific Health Research and Education Institute

location_facility: Seoul National University Bundang Hospital

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

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

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: CHU de Grenoble - Hôpital Albert Michallon

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

location_facility: Carl T. Hayden Veterans Administration Medical Center

location_facility: Harbin medical university cancer hospital

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Hospital Privado Universitario de Córdoba

location_facility: Taipei Medical University Shuang Ho Hospital

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

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie


title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

acronym: DELTA 1

summary:
This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

enrollment_type: Actual

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Poland
United Kingdom
Italy
Canada
France
Germany


title: A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Spain
Italy
Georgia
Australia
Netherlands
Russian Federation
Thailand
Ukraine
Korea, Republic of
United States
France
China
Turkey
Japan
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Onkologische Scwerpunktpraxis Leer - Emden

location_facility: Providence Medical Foundation Santa Rosa

location_facility: Komunalne Nekomertsiine Pidryiemstvo Oblasnyi Tsentr Onkolohii

location_facility: Beijing Chest Hospital, Capital Medical University

location_facility: Hospices Civils de Lyon-Hôpital de la Croix Rousse

location_facility: State Budgetary Healthcare Institution "City Clinical Hospital #1"

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Tianjin Medical University General Hospital

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

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Public Non-profit Institution "Kyiv City Clinical Oncology Center"

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: Multiprofile Clinic Consilium Medula LTD

location_facility: Hospital Universitario Insularde Gran Canaria

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

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Arkhangelsk Regional Clinical Oncological Dispensary

location_facility: Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical"

location_facility: Komunalne Nekomertsiine Pidryiemstvo - Miska Klinichna Likarnia #4

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kobe City Medical Center General Hospital

location_facility: Cancer Center of Guangzhou Medical University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Cancer Hospital of Guangxi Zhuang Autonomous Region

location_facility: Affiliated Hospital of North Sichuan Medical College

location_facility: Acad. Fridon Todua medical Center LTD - Research Institute of Clinical Medicine LTD

location_facility: The Smorodintsev Research Institute of Influenze

location_facility: Universitaetsklinikum Ulm, Innere Medizin III

location_facility: Srinagarind Hospital (Khon Kaen University)

location_facility: The First Affiliated Hospital of Zhengfzhou University

location_facility: State Budgetary Healthcare Institution-Chelyabinsk Regional Clinical Center of Oncology and Nuclear

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Volyn Regional Medical Center of Oncology

location_facility: Hospices Civils de Lyon- Hopital Louis Pradel

location_facility: Medical Center "Verum" Limited Liability Company

location_facility: Fujian Medical University Union Hospital

location_facility: The Second Hospital of Anhui Medical University

location_facility: Klinikum Ludwigshafen, Medizinische Klinik A

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: FSBI "Clinical Research and Practical Center for Specialized Medical Care (Oncology)"

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: FSBI "National Medical Research Center for Oncology N.A.N.N. Petrov" of the MOH of the RF

location_facility: Communal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GMBH

location_facility: Istanbul Medeniyet Uni Goztepe Training & Res Hosp

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Stichting Het Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Chu Tours - Hopital Bretonneau - Service Pneumologie 2

location_facility: State Budgetary Healthcare Institution-Regional Oncology Dispensary Number 2

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością

location_facility: Private Healthcare Institution - Clinical Hospital Russian Railways - Medicine of the City of St. Petersburg

location_facility: HealthPartners Institute - MMCORC (Metro Minnesota Community Oncology Research Consortium)

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region

location_facility: Timi - Tbilisi Institute of Medicine LTD

location_facility: Centre Hospitalier de la Cote Basque - Saint Léon - Service de Pneumologie

location_facility: Hospital General Universitario Morales Meseguer

location_facility: The Fourth Affiliated Hospital Zhejinaang University School of Medicine

location_facility: Private Medical Institution "Evromedservis"

location_facility: West Jefferson Medical Center Cancer Center (University Medical Center New Orleans)

location_facility: Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

location_facility: BIH of OMSK Region "Clinical Oncology Dispensary"

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: The Catholic University of Korea Eunpyeong St. Mary's Hospital

location_facility: Baskent University Practice and Research Hospital Adana - Medical Oncology Department

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Istituto Romagnolo per Studio, dei Tumori "Dino Amadori"

location_facility: Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Morodov"

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: National Taiwan University Hospital Yunlin Branch

location_facility: Daping Hospital, Third Military Medical University

location_facility: Hospital Regional Universitario de Malaga

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: Israel-Georgian Medical Research Clinic Helsicore LTD

location_facility: Calvary Mater Newcastle, Medical Oncology Trial Unit, Edith Street

location_facility: West Penn Hospital (Allegheny Health Network)

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Zakarpatska Regional Clinical Oncological Center

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: The Catholic University of Korea, Bucheon St. Mary's Hospital

location_facility: State Budgetary Healthcare Institution - Samara Regional Clinical Oncology Dispensary

location_facility: State Budgetary Healthcare Institution - Nizhny Novgorod Regional Clinical Oncology Dispensary

location_facility: State Autonomous Healthcare Institution - Republican Clinical Oncological Dispensary of the Republic

location_facility: UAB O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham

location_facility: Ocala Oncology, Florida Cancer Affiliates

location_facility: Klinikum Der Universitat muenchen - Campus Innenstadt

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Songklanagarind Hospital (Prince of Songkhla University)

location_facility: Lviv State Regional Oncology Treatment and Diagnostic Center


title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

summary:
In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment.

Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Russian Federation
India
Turkey
Mexico
Norway
Malaysia
Slovakia
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Chile


title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

source: euctr

location_country:
Spain
Italy
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Centro De Estudio Y Prevencion Del Cancer

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: University of California Irvine Medical Center

location_facility: University Hospitals Seidman Cancer Center

location_facility: Ryazan State Medical University named after I.P.Pavlov

location_facility: The Male/Female Health and Research Centre

location_facility: Sefako Makgatho Health Sciences University

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Centro Regional Integrado de Oncologia - CRIO

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Centro Hospitalar de Trás os Montes e Alto-Douro

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: Pusan National University Yangsan Hospital

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

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

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani

location_facility: Uniwersytet Medyczny w Lublinie - Katedra i Klinika Urologii i Onkologii Urologicznej

location_facility: N. N. Blokhin Russian Academy of Medical Sciences

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Fundação Hospitalar São Francisco de Assis

location_facility: State Institution Academy Of Medical Sciences Of Ukraine

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

location_facility: Consultorio Privado Dr Jose Arturo Rodriguez Rivera

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Indira Gandhi Institute of Medical Sciences

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: Columbia University Medical Center, Herbert Irving Pavilion

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Acharya Tulsi Regional Cancer Treatment Research Institute

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Wuhan Tongji Hospital, Tongji Medical College

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cardiology Clinic at Montefiore Hutchinson Complex

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Winship Cancer Institute of Emory University

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Guangzhou First Municipal People's Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

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

location_facility: Hygeia Diagnostic & Therapeutic Center Of Athens

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

location_facility: T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: General Hospital of Western Theater Command PLA

location_facility: FSBHI RSCRST n.a. Ac. Granov A.M. of MoH

location_facility: Shengjing Hospital of China Medical University

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: West China Hospital of Sichuan University

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Severo-Zapadnyy Gosudarstvennyy Meditsinskiy Universitet Im. I. I. Mechnikova

location_facility: State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio

location_facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

location_facility: P.L. Shupyk National Medical Academy of Post-Graduate Education

location_facility: Waldkrankenhaus St. Marien -Urologische Universitätsklinik

location_facility: CEDIC Centro de Investigaciones Clinicas

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Marien-Krankenhaus GmbH Bergisch Gladbach

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: Institut Regional du Cancer de Montpellier

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Fondazione del Piemonte per I'Oncologia IRCC Candiolo

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte

location_facility: Attikon University General Hospital of Attica

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: Oleksandrivska Clinical Hospital of Kyiv City, Infectional Department #2

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

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Sujan Surgical Cancer Hospital & Amravati Cancer Foundation

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: MIH V.I. Shapoval Regional Clinical Centre of Urology and Nephrology

location_facility: CRYPTEX Investigacion clinica S.A De C.V

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Hospital Regional do Câncer - Hospital de Esperança

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Post Graduate Institute of Medical Education & Research (PGIMER)

summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.


status: Terminated

acronym: TRISTARDS

intervention_type: Procedure

title: The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Denmark
Poland
Brazil
Portugal
Romania
Italy
Austria
Mexico
Netherlands
Argentina
Russian Federation
Spain
France
India
Malaysia
South Africa
Belgium
Turkey
Germany

location_facility: Clin. Hos. of Infectious and Tropical Diseases "Victor Babes"

location_facility: Matei Bals Institute of Infectious Disease, Bucharest

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Hospital General de Occidente de la Secretaría de Salud Jalisco

location_facility: City Clinical Hospital No. 15, St. Petersburg

location_facility: St. Luke's Hospital in Boleslawiec Center for Prevention and Treatment of Strokes

location_facility: Faculdade de Medicina de Botucatu - UNESP

location_facility: Pokrovskaya City Hospital, St.Petersburg

location_facility: Bangalore Medical College and Research Institute

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: State Budget Institution of Healthcare Leningradskaya region "Kirovskaya Interdistrict Hospital"

location_facility: State Budgetary Institution of Healthcare "Clinical Hospital No. 4"

location_facility: Sureyyapasa Gogus Hast. ve Gogus Cer. Egit. ve Aras. Has.

location_facility: Servicios Hospitalarios de México S.A. de C.V.

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Wiener Gesundheitsverbund Klinik Favoriten

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

location_facility: City Clinical Hospital # 40 of the Moscow Health Department

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi

location_facility: Maharaja Agrasen Superspeciality Hospital

summary:
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster.

The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment.

Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month.

Participants are in the study for 3 months.


ipd_sharing: No

title: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

lead_sponsor: Constellation Pharmaceuticals

ReferenceCitation: Mascarenhas J, Kremyanskaya M, Patriarca A, Harrison C, Bose P, Rampal RK, Palandri F, Devos T, Passamonti F, Hobbs G, Talpaz M, Vannucchi A, Kiladjian JJ, Verstovsek S, Hoffman R, Salama ME, Chen D, Taverna P, Chang A, Colak G, Klein S, Gupta V. MPN-375 BET Inhibitor Pelabresib (CPI-0610) Combined With Ruxolitinib in Patients With Myelofibrosis - JAK Inhibitor-Naïe or With Suboptimal Response to Ruxolitinib - Preliminary Data From the MANIFEST Study. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S335-S336. doi: 10.1016/S2152-2650(22)01456-2.

ReferenceCitation: Harrison CN, Gupta VK, Gerds AT, Rampal R, Verstovsek S, Talpaz M, Kiladjian JJ, Mesa R, Kuykendall AT, Vannucchi AM, Palandri F, Grosicki S, Devos T, Jourdan E, Wondergem MJ, Al-Ali HK, Buxhofer-Ausch V, Alvarez-Larrán A, Patriarca A, Kremyanskaya M, Mead AJ, Akhani S, Sheikine Y, Colak G, Mascarenhas J. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis. Future Oncol. 2022 Sep;18(27):2987-2997. doi: 10.2217/fon-2022-0484. Epub 2022 Aug 11. Review.

location_country:
Poland
Taiwan
Hong Kong
Spain
Greece
Austria
Australia
Italy
Canada
Thailand
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Netherlands
Czechia

location_facility: IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

location_facility: Loyola University - Cardinal Bernardin Cancer Center

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: ICO Girona - Hospital Universitari de Girona

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL

location_facility: London Health Sciences Center - Victoria Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute

location_facility: The Catholic University of South Korea Seoul St. Mary's Hospital

location_facility: LKH - Universitätsklinikum Graz; Abteilung für Hämatologie

location_facility: Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: General Hospital, School of Medicine National and Kapodistrian University of Athens

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Peninsula Private Hospital Clinical Trials Unit

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Weill Cornell Medical College- New York Presbyterian Hospital

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Daegu Catholic University Medical Center

location_facility: Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi

location_facility: Mays Cancer Center at UT Health San Antonio MD Anderson

location_facility: Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital

location_facility: CHU DE NIMES _Institut de Cancérologie du Gard

location_facility: The Catholic University Of Korea St. Vincent Hospital

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

location_facility: Srinagarind hospital,Khon Kaen University

location_facility: Franciscan Health/Indiana blood and Marrow Transplantation

location_facility: Hospital Universitario Central de Asturias

location_facility: Cha Bundang Medical Center Cha University

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

summary: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.


acronym: STARSCAPE-OLE

title: A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
Ukraine
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Canada
Hungary
China
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

location_facility: Chelyabinsk Regional Clinical Hospital; Hematology

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

location_facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary

location_facility: Barzilai Medical Center; Neurology Department

location_facility: Tianjin Medical University General Hospital

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Akdeniz University Faculty of Medicine Department of Pulmonology

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: University of Florida Health Pulmonology - Jacksonville

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: National and Kapodistrian University of Athens EKPA Medical School

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital Virgen de las Nieves; Servicio de Neumologia

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Servie de Pneumologie et centre de Transplantation Pulmonaire

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute

location_facility: University Hospital of Ioannina; Pulmonology Department

location_facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

location_facility: Eriyes universitesi Tıp Fakultesi Hastanesi

location_facility: Centro de Diagnóstico y Tratamiento de Enfermedades Respiratorias, Medica San Isidro

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Uppsala Universitet - Akademiska Sjukhuset

location_facility: Kobe City Medical Center General Hospital

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali; Onkologi

location_facility: University of Louisville Health Sciences Center

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Unidad Médica para la Salud Integral UMSI

location_facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

location_facility: Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

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

location_facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

location_facility: Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: The Third Xiangya Hospital Of Central South University

location_facility: Fondazione IRCCS Policlinico San Matteo; Divisione di Ematologia Dipartimento di Onco-Ematologia

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

location_facility: The University of Hong Kong; Queen Mary Hospital

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia

location_facility: Marmara Universitesi Hastanesi Marmara University Hospital

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: Ospedale Morgagni Pierantoni; Patologia clinica

location_facility: Into Research; Life Groenkloof Hospital Medical Centre

location_facility: University of Thessaly Faculty of Medicine

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Investigaciones en Patologias Respiratorias

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Centro Medico de Enfermedades Respiratorias (CEMER)

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Moscow State Medical and Dental University n. a. A.I. Evdokimova

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Evangelismos Hospital; Endocrinology, Diabetes & Metabolism

location_facility: Advanced Pulmonary & Sleep Research Institute of Florida

location_facility: Fundacion Respirar (Centro Medico Dra. De Salvo)

location_facility: Shengjing Hospital of China Medical University

location_facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Far Eastern Memorial Hospital; Department of Clinical Pathology

location_facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: The Catholic University of Korea Bucheon St. Mary's Hospital

location_facility: Christiana Care Pulmonary Associates - Newark

location_facility: Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Thomayerova nemocnice; Lekarna - pavilon H

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

location_facility: Hospital Ramón y Cajal;Servicio de Neumología

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: University of Texas Medical Branch at Galveston

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

location_facility: University General Hospital of Heraklion

location_facility: Peking Union Medical College Hospital; Pharmacy

location_facility: Centro de Alergia y Enfermedades Respiratorias

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

location_facility: Hebei Medical University - The Second Hospital

location_facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

location_facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Clinica Universidad de Navarra ; Servicio de Farmacia

summary: This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

summary: The objectives of this study are to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

status: Active, not recruiting

lead_sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Australia
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Germany
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Medizinische Hochschule Hannover (Site 1505)

location_facility: Severance Hospital Yonsei University Health System - PPDS (Site 3101)

location_facility: University of Colorado Hospital (Site 1013)

location_facility: The George Washington University Medical Faculty Associates (Site 1025)

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: Hospital Universitario Marques de Valdecilla (Site 1601)

location_facility: Renown Institute for Heart & Vascular Health (Site 1055)

location_facility: University of Kansas Medical Center (Site 1020)

location_facility: Thoraxklinik-Heidelberg gGmbH (Site 1509)

location_facility: Washington University School of Medicine (Site 1022)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

location_facility: Hospital Clinico Universitario de Salamanca (Site 1608)

location_facility: University of Cincinnati Medical Center (Site 1035)

location_facility: UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

location_facility: Stanford University Medical Center (Site 1024)

location_facility: Golden Jubilee National Hospital (Site 1204)

location_facility: University of Washington Medical Center - Montlake (Site 1067)

location_facility: Lady Davis Carmel Medical Center (Site 1705)

location_facility: Instituto do Coracao - HC FMUSP ( Site 1803)

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

location_facility: University Of Alberta Hospital ( Site 2101)

location_facility: University of California - Davis Medical Center (Site 1064)

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044)

location_facility: Hospital Universitario Ramon y Cajal (Site 1609)

location_facility: Hopitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: Hopital Arnaud de Villeneuve ( Site 1301)

location_facility: Hospital Universitario Marques de Valdecilla (Site 1603)

location_facility: Centre Hospitalier Universitaire de Bicetre ( Site 1304)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

location_facility: Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801)

location_facility: Royal Free London NHS Foundation Trust (Site 1202)

location_facility: Institute of Cardiovascular Diseases Dedinje (Site 2903)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505)

location_facility: University of California San Diego Medical Center (Site 1002)

location_facility: Waikato District Health Board (Site 2702)

location_facility: Sahlgrenska Universitets Sjukhuset (Site 3201)

location_facility: Medical University of South Carolina - PPDS (Site 1003)

location_facility: Universita "La Sapienza" Policlinico Umberto I (Site 2402)

location_facility: The Ohio State University Wexner Medical Center (Site 1032)

location_facility: Norton Pulmonary Specialists (Site 1066)

location_facility: Vanderbilt University Medical Center (Site 1027)

location_facility: CHU Nantes - Hopital Laennec (Site 1309)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

location_facility: University Clinical Center Nis (Site 2904)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: Statcare Pulmonary Consultants - Knoxville (Site 1031)

location_facility: University of Ottawa Heart Institute ( Site 2104)

location_facility: Arizona Pulmonary Specialists (Site 1010)

location_facility: Hospital Clinic de Barcelona (Site 1602)

location_facility: Hopitaux Universitaires de Geneve HUG (Site 3302)

location_facility: New York Presbyterian Hospital (Site 1046)

location_facility: Gachon University Gil Medical Center (Site 3103)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: Imperial College Healthcare NHS Trust (Site 1203)

location_facility: Seoul National University Hospital (Site 3102)

location_facility: Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501)

location_facility: CHRU Brest - Hopital Cavale Blanche (Site 1314)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: Oregon Health and Science University (Site 1054)

location_facility: Brigham and Women's Hospital (Site 1014)

location_facility: University Hospitals Cleveland Medical Center (Site 1005)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2201_

location_facility: Saint Vincents Hospital Sydney ( Site 1102)

location_facility: Institut Klinicke a Experimentalni Mediciny ( Site 2202)

location_facility: Maastricht University Medical Center (Site 2603)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 1303)

location_facility: Universitaetsklinik Regensburg (Site 1503)

location_facility: Duke University Medical Center (Site 1026)

location_facility: University of Otago, Wellington (Site 2701)

location_facility: Hospital Universitari Vall d'Hebron (Site 1605)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802)


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis

summary:
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.

The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

ipd_sharing_description: Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Poland
Spain
Greece
Austria
Australia
Italy
Canada
Netherlands
Russian Federation
Switzerland
United Kingdom
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility:
Clinical Trial Site
Clincal Trial Site

intervention_type: Other


title: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

summary:
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices.

The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Portugal
Spain
Italy
Greece
United Kingdom
Switzerland
United States
France
Slovakia

location_facility: Cardiovascular Consultants Medical Group (Van Nuys CA)

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Washington University School of Medicine

location_facility: Azienda ospedaleria Santa Maria dellaMisericordia di Udine

location_facility: Hospital da Senhora da Oliveira -Guimarães

location_facility: Centre Hospitalier Universitaire Saint Étienne

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

location_facility: Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

location_facility: Central Manchester University Hospitals NHS - mancester Royal Infirmary

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: Presidio Ospedaliero Centrale - SS.Annunziata

location_facility: Brigham and Women's Hospital (Boston MA)

location_facility: North Memorial Health Heart & Vascular Center

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: Centro Hospitalar Universitário de SãoJoão Alameda

location_facility: Consultants in Cardiology (Fort Worth TX)

location_facility: Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

location_facility: NewYork-Presbyterian/Columbia University Irving Medical Center

location_facility: Azienda Ospedaliera ospedale Niguarada ca Granda

location_facility: MedStar Health Research Institute (Baltimore)

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

location_facility: Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: The James Cook University Hospital - SouthTees Hospitals NHS

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

location_facility: Hospital Clínico Universitario de Valladolid

intervention_type: Device


title: Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

summary: Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Washington University School of Medicine

location_facility: Centro Hospitalar Universitário de São João

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: New York-Presbyterian Hospital/Weill-Cornell Medical Center

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: Cardiovascular Consultants Medical Group

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, a.s.)

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: North Memorial Heart and Vascular Institute