title: 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

lead_sponsor: AstraZeneca

location_country:
Denmark
Italy
Mexico
Argentina
France
South Africa
Belgium
Norway
Sweden


status: Completed

primary_purpose: Treatment

intervention_type: Drug

acronym: Phase IIb/III NSCLC Iressa/Tarceva Failures

title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)

study_completion_date_type: Actual

lead_sponsor: Boehringer Ingelheim

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26. Erratum in: Lancet Oncol. 2012 May;13(5):e186.

enrollment_type: Actual

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Canada
Thailand
Korea, Republic of
United States
France
China
Singapore
Belgium
Germany

location_facility: 1200.23.65001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88601 National Taiwan University Hospital

location_facility: 1200.23.1005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.046 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.85202 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.024 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3302B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.027 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.029 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3402 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3304B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)

location_facility: 1200.23.3405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.056 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.026 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88606 National Cheng Kung University Hospital

location_facility: 1200.23.88603 Chang Gung Memorial Hosp-Linkou

location_facility: 1200.23.88604 Taichung Veterans General Hospital

location_facility: 1200.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49010 Zentralklinik Bad Berka GmbH

location_facility: 1200.23.32004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.038 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3302A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49004 Johannes Gutenberg-Universität Mainz

location_facility: 1200.23.050 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3301A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.045 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3306C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3304A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.028 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.020 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88607 Tri-Service General Hospital

location_facility: 1200.23.4405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.039 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3305A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3307A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4406 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3303C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88605 China Medical University Hospital

location_facility: 1200.23.49003 Asklepios Fachkliniken München-Gauting

location_facility: 1200.23.3306A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH

location_facility: 1200.23.1002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.013 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3303A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3406 Boehringer Ingelheim Investigational Site

summary:
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

lead_sponsor_type: industriel

status_simplified: Completed


title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

summary:
This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

ReferenceType: result

ReferenceCitation: Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. Erratum in: Diabetes Care. 2007 Apr;30(4):1035.

ReferenceCitation: Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

summary: Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Czech Republic
Sweden
Hungary
France
Belgium
Germany

location_facility: 511.118.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35803 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.118.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.118.39001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.118.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.118.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.118.3306A Boehringer Ingelheim Investigational Site

location_facility: 511.118.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.118.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.118.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.118.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42001 Boehringer Ingelheim Investigational Site


acronym: MTX-IR Study

title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

ReferenceCitation: Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.

ReferenceCitation: Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.

location_country:
United Kingdom
Italy
United States
Peru
Belgium
South Africa
Poland
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands

location_facility: Allergy & Rheumatology Medical Clinic, Inc.

location_facility: Rheumatology Associates Of Central Florida

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Albuquerque Rehabilitation & Rheumatology Pc

location_facility: Arthritis & Osteoporosis Treatment Center, Pa

location_facility: Boise Rheumatology/ Intermountain Research Center, Inc

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Rheumatic Disease Clinical Research Center, Llc

location_facility: Valerius Medical Group &Research Ctr. Of Greater Long Beach

location_facility: Arthritis And Rheumatic Disease Specialties

location_facility: Center For Arthritis & Rheumatic Diseases, Pc

location_facility: Asheville Rheumatology & Osteoporosis Research Asso P. A.

location_facility: South Puget Sound Clinincal Research Center

location_facility: Oklahoma Center For Arthritis Therapy And Research

location_facility: The Arthritis Clinic & Carolina Bone & Joint

summary: The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


title: An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

ReferenceCitation: Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, Johannsdottir HK, Klughammer B, Gonzalez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012 Mar;13(3):300-8. doi: 10.1016/S1470-2045(11)70385-0. Epub 2012 Jan 24.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
Venezuela
Romania
Belgium
South Africa
Poland
Slovenia
Austria
Australia
Russian Federation
Malaysia
Slovakia
Canada
Hungary
China
Germany
Denmark
Greece
New Zealand
Czech Republic
Korea, Republic of
France
Chile


intervention_type: Other

acronym: POS Phase 3

title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.

lead_sponsor: UCB Pharma SA

ReferenceCitation: Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.

ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

ReferenceCitation: Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

ReferenceCitation: Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum in: Epilepsy Res. 2017 Nov;137:165-166.

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.

ReferenceCitation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3:CD011501. doi: 10.1002/14651858.CD011501.pub3. Review.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Finland
Switzerland
Hungary
France
India
Belgium
Germany

summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


title: A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia

summary: To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

lead_sponsor: Sunovion

location_country:
Croatia
Poland
Serbia
United Kingdom
Austria
Russian Federation
Ukraine
Hungary
France
Romania


title: A Multinational, Prospective, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Sequential Intravenous/Oral Moxifloxacin in Comparison to Intravenous Levofloxacin Plus Intravenous Ceftriaxone Followed by Oral Levofloxacin, in the Treatment of Patients With Severe Community-acquired Pneumonia

summary: Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

ReferenceCitation: Torres A, Garau J, Arvis P, Carlet J, Choudhri S, Kureishi A, Le Berre MA, Lode H, Winter J, Read RC; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial. Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.

lead_sponsor: Bayer

location_country:
Poland
Belgium
Portugal
Spain
Greece
United Kingdom
Mexico
Netherlands
Argentina
Lithuania
Sweden
France
Chile
Israel
Peru
Colombia
South Africa
Germany


title: A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

acronym: LUCID

summary: This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

status: Terminated

ReferenceType: background

ReferenceCitation: Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.

ReferenceCitation: Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. Epub 2007 Nov 21.

ReferenceCitation: Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55.

ReferenceCitation: Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.

lead_sponsor: Biogen

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Slovakia
Brazil
Canada
Germany
Greece
New Zealand
Czech Republic
France

status_simplified: Unknown


acronym: S-TRAC

title: Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

lead_sponsor: Pfizer

type: Other Identifier

study_start_date_type: Actual

ReferenceCitation: Patel A, Ravaud A, Motzer RJ, Pantuck AJ, Staehler M, Escudier B, Martini JF, Lechuga M, Lin X, George DJ. Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting. Future Oncol. 2021 Feb;17(4):403-409. doi: 10.2217/fon-2020-0652. Epub 2020 Oct 8.

ReferenceCitation: Ouzaid I, Kammerer-Jacquet SF, Khene Z, Ravaud A, Patard JJ, Bensalah K, Rioux-Leclercq N. Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients. Front Surg. 2020 Jun 5;7:26. doi: 10.3389/fsurg.2020.00026. eCollection 2020.

ReferenceCitation: Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.

ReferenceCitation: Rini BI, Escudier B, Martini JF, Magheli A, Svedman C, Lopatin M, Knezevic D, Goddard AD, Febbo PG, Li R, Lin X, Valota O, Staehler M, Motzer RJ, Ravaud A. Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib. Clin Cancer Res. 2018 Sep 15;24(18):4407-4415. doi: 10.1158/1078-0432.CCR-18-0323. Epub 2018 May 17.

ReferenceCitation: George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study. Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.

ReferenceCitation: Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.

ReferenceCitation: Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9.

location_country:
Spain
Italy
United Kingdom
United States
Czechia
Poland
Australia
Israel
Mexico
Sweden
Malaysia
Slovakia
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Colombia

location_facility: Universitaetsklinikum Ulm, Urologische Universitaetsklinik

location_facility: Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck

location_facility: IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro

location_facility: Fakultni nemocnice v Motole, Klinika zobrazovacich metod

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: St. Mary's Hospital, Imperial College, Health care NHS Trust

location_facility: Department of Urology,Peking University First Hospital

location_facility: Department of Internal Medicine, Seoul National University Bundang Hospital

location_facility: Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Post Graduate Medical School, University of Surrey

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie

location_facility: Fudan University Cancer Hospital, Department of Urology

location_facility: Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie

location_facility: Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

location_facility: Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie

location_facility: Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services

location_facility: Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: The University of North Carolina at Chapel Hill

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona

location_facility: Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Charite Universitaetsmedizin Berlin, Campus Charite Mitte

location_facility: Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi

location_facility: Chinese PLA General Hospital/Urology Department

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: Onkologisches Institut, Inselspital Bern

location_facility: Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny

location_facility: Tianjin Oncology Hospital, urology department

location_facility: Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie

location_facility: "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Eberhardt-Karls-Universität Tübingen, Klinik für Urologie

location_facility: The first affiliated hospital of Soochow university/Department of Urology

location_facility: Norrlands universitetssjukhus, Urologiska kliniken

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A

location_facility: Urology Department, South-Western Hospital, 3rd Military Medical University.

location_facility: P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica

location_facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

location_facility: Urology Department, Sun Yet-Sen University Cancer Center

location_facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie

location_facility: Institut Claudius Regaud - Centre de Lutte Contre le Cancer

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II

location_facility: Medical Oncology, Patterson institute for Cancer Research

location_facility: Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.

location_facility: Department of Urology, Shanghai Changhai Hospital

location_facility: Fakultni nemocnice v Motole, Ustav nuklearni mediciny

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie

location_facility: Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

location_facility: Instituto Nacional de Cancerologia - ESE

summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.


title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

location_country:
Spain
Ireland
Austria
Netherlands
United Kingdom
Finland
Switzerland
France
Germany

summary:
This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).


title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.

summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

ReferenceCitation: Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drüeke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.

ReferenceCitation: Drüeke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84.

location_country:
Spain
Italy
United Kingdom
Belgium
Poland
Hong Kong
Portugal
Austria
Russian Federation
Turkey
Mexico
Norway
Sweden
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Czech Republic
Thailand
France


title: A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

summary: The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

lead_sponsor: Abbott

location_country:
Poland
Taiwan
Spain
Greece
Ireland
Australia
Italy
Canada
Czech Republic
Netherlands
Russian Federation
Switzerland
Puerto Rico
United States
France
Singapore
United Kingdom
Belgium
Germany

location_facility:
Site Reference ID/Investigator# 217
Site Reference ID/Investigator# 827
Site Reference ID/Investigator# 177
Site Reference ID/Investigator# 876
Site Reference ID/Investigator# 294
Site Reference ID/Investigator# 297
Site Reference ID/Investigator# 200
Site Reference ID/Investigator# 1154
Site Reference ID/Investigator# 209
Site Reference ID/Investigator# 874
Site Reference ID/Investigator# 268
Site Reference ID/Investigator# 175
Site Reference ID/Investigator# 237
Site Reference ID/Investigator# 228
Site Reference ID/Investigator# 280
Site Reference ID/Investigator# 193
Site Reference ID/Investigator# 246
Site Reference ID/Investigator# 241
Site Reference ID/Investigator# 267
Site Reference ID/Investigator# 220
Site Reference ID/Investigator# 844
Site Reference ID/Investigator# 191
Site Reference ID/Investigator# 783
Site Reference ID/Investigator# 849
Site Reference ID/Investigator# 873
Site Reference ID/Investigator# 288
Site Reference ID/Investigator# 279
Site Reference ID/Investigator# 270
Site Reference ID/Investigator# 224
Site Reference ID/Investigator# 179
Site Reference ID/Investigator# 227
Site Reference ID/Investigator# 273
Site Reference ID/Investigator# 289
Site Reference ID/Investigator# 281
Site Reference ID/Investigator# 226
Site Reference ID/Investigator# 244
Site Reference ID/Investigator# 234
Site Reference ID/Investigator# 235
Site Reference ID/Investigator# 233
Site Reference ID/Investigator# 271
Site Reference ID/Investigator# 275
Site Reference ID/Investigator# 223
Site Reference ID/Investigator# 236
Site Reference ID/Investigator# 232
Site Reference ID/Investigator# 249
Site Reference ID/Investigator# 265
Site Reference ID/Investigator# 848
Site Reference ID/Investigator# 214
Site Reference ID/Investigator# 185
Site Reference ID/Investigator# 210
Site Reference ID/Investigator# 254
Site Reference ID/Investigator# 186
Site Reference ID/Investigator# 851
Site Reference ID/Investigator# 221
Site Reference ID/Investigator# 178
Site Reference ID/Investigator# 266
Site Reference ID/Investigator# 216
Site Reference ID/Investigator# 195
Site Reference ID/Investigator# 292
Site Reference ID/Investigator# 826
Site Reference ID/Investigator# 225
Site Reference ID/Investigator# 206
Site Reference ID/Investigator# 229
Site Reference ID/Investigator# 264
Site Reference ID/Investigator# 284
Site Reference ID/Investigator# 198
Site Reference ID/Investigator# 872
Site Reference ID/Investigator# 298
Site Reference ID/Investigator# 263
Site Reference ID/Investigator# 231
Site Reference ID/Investigator# 182
Site Reference ID/Investigator# 877
Site Reference ID/Investigator# 174
Site Reference ID/Investigator# 296
Site Reference ID/Investigator# 824
Site Reference ID/Investigator# 846
Site Reference ID/Investigator# 1157
Site Reference ID/Investigator# 870
Site Reference ID/Investigator# 784
Site Reference ID/Investigator# 845
Site Reference ID/Investigator# 208
Site Reference ID/Investigator# 215
Site Reference ID/Investigator# 199
Site Reference ID/Investigator# 218
Site Reference ID/Investigator# 871
Site Reference ID/Investigator# 274
Site Reference ID/Investigator# 290
Site Reference ID/Investigator# 1155
Site Reference ID/Investigator# 238
Site Reference ID/Investigator# 173
Site Reference ID/Investigator# 1156
Site Reference ID/Investigator# 243
Site Reference ID/Investigator# 278
Site Reference ID/Investigator# 825
Site Reference ID/Investigator# 823
Site Reference ID/Investigator# 245
Site Reference ID/Investigator# 184
Site Reference ID/Investigator# 205
Site Reference ID/Investigator# 176
Site Reference ID/Investigator# 183
Site Reference ID/Investigator# 192
Site Reference ID/Investigator# 189
Site Reference ID/Investigator# 201
Site Reference ID/Investigator# 188
Site Reference ID/Investigator# 181
Site Reference ID/Investigator# 211
Site Reference ID/Investigator# 219
Site Reference ID/Investigator# 190
Site Reference ID/Investigator# 196
Site Reference ID/Investigator# 207
Site Reference ID/Investigator# 850
Site Reference ID/Investigator# 2450
Site Reference ID/Investigator# 262
Site Reference ID/Investigator# 203
Site Reference ID/Investigator# 875
Site Reference ID/Investigator# 172
Site Reference ID/Investigator# 286
Site Reference ID/Investigator# 256
Site Reference ID/Investigator# 5163
Site Reference ID/Investigator# 180
Site Reference ID/Investigator# 194
Site Reference ID/Investigator# 213
Site Reference ID/Investigator# 1153
Site Reference ID/Investigator# 282
Site Reference ID/Investigator# 222
Site Reference ID/Investigator# 299
Site Reference ID/Investigator# 843
Site Reference ID/Investigator# 792
Site Reference ID/Investigator# 257


title: Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)

summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

primary_purpose: Prevention

ReferenceCitation: Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.

ReferenceCitation: Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

ReferenceCitation: Medina DM, Valencia A, de Velasquez A, Huang LM, Prymula R, García-Sicilia J, Rombo L, David MP, Descamps D, Hardt K, Dubin G; HPV-013 Study Group. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls. J Adolesc Health. 2010 May;46(5):414-21. doi: 10.1016/j.jadohealth.2010.02.006.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Taiwan
Spain
Australia
Honduras
Czech Republic
Sweden
Korea, Republic of
France
Panama
Colombia
Norway
Germany

intervention_type: Biological


title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).

summary: This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

ReferenceCitation: Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. Review.

ReferenceCitation: Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, López de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.

location_country:
Denmark
Poland
Romania
Slovenia
Italy
Austria
Netherlands
Russian Federation
Spain
Czech Republic
Switzerland
United Kingdom
Hungary
France
Turkey
Belgium
Germany
Bulgaria


title: A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial

summary: The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

ReferenceCitation: Böttiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.

location_country: Spain Italy Austria Switzerland Sweden France Belgium Norway Germany

location_facility: Akuttklinikken / NLA, Sentralsjukehuset i Rogaland

location_facility: Hospital Clínico San Carlos / Hemodynamics

location_facility: Hospital Universitario Reina Sofía / ICU

location_facility: Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg

location_facility: Hospital Clínico Universitario Vírgen de la Victoria / ICU

location_facility: Hospital Clínico Provincial de BCN / Cardiology Service

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Univ.-Klinik f. Anaesthesie u. Intensivmedizin

location_facility: Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429

location_facility: Vírgen de las Nieves. Critical Care-Emergency Room

location_facility: Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg

location_facility: Complejo Hospitalario Universitario de Vigo / Cardiology

location_facility: Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg


title: A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study

summary:
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

location_country:
Denmark
Taiwan
Portugal
Spain
Italy
Russian Federation
Czech Republic
Ukraine
Korea, Republic of
France
Malaysia
Germany
Slovakia

location_facility: Associac?o Protectora dos Diabeticos de Portugal

location_facility: Russian Academy for Advanced Medical Studies

location_facility: Azienda Ospedaliera S. Maria degli Angeli

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism

location_facility: Institute of Diabetic pathology problems

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: Regional Clinical Scientific Research Institute

location_facility: National Endocrinology Research Center of Russia

location_facility: Keimyung University Dongsan Medical Center

location_facility: Azienda Ospedaliera Policlinico S. Orsola Malpighi


title: An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

summary: The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

ReferenceCitation: Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Spain Ireland Italy Canada Sweden France Belgium Netherlands


title: A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

ReferenceCitation: Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4.

ReferenceCitation: Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Müller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.

ReferenceCitation: Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Müller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

location_facility: The University Of North Carolina At Chapel Hill

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Washington University School Of Medicine

location_facility: Washington Cancer Institute At Washington Hospital Center

location_facility: The University Of Texas Md Anderson Cancer Center


title: A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

ReferenceCitation: Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734.

ReferenceCitation: Müller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

ReferenceCitation: Shah NP, Kantarjian HM, Kim DW, Réa D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.

ReferenceCitation: Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20.

ReferenceCitation: Shah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brümmendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Ireland
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Oncology Hematology Associates Of Central Illinois, Pc

location_facility: University Of North Carolina At Chapel Hill

location_facility: Ventura County Hematology-Oncology Specialists


title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

ReferenceCitation: Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.

ReferenceCitation: Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

ReferenceCitation: Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

ReferenceCitation: Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.

ReferenceCitation: McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.

ReferenceCitation: Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.

ReferenceCitation: Weber JS, Dummer R, de Pril V, Lebbé C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.

ReferenceCitation: Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.

ReferenceCitation: Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum in: N Engl J Med. 2010 Sep 23;363(13):1290.

location_country:
Brazil
United Kingdom
Netherlands
Argentina
Canada
Switzerland
Hungary
United States
Chile
France
South Africa
Belgium
Germany

location_facility: Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD

location_facility: University of North Carolina at Chapel Hill

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Indiana Oncology Hematology Consutants of Noblesville

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Yale University School of Medicine - Oncology Outpatient Clinic

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Henry Ford Medical Center- West Bloomfield

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: Hospital de Cancer de Barretos - Fundacao Pio XII

location_facility: Dermatologische Klinik Universitatsspital Zurich

location_facility: Columbia University Medical Center, Irving Center for Clinical Research

location_facility: Hospital Municipal de Oncoligia Maria Curie

location_facility: Hospital Municipal de Oncologia Maria Curie

location_facility: Santo Andre Diagnosticos e Tratamentos Ltda.

location_facility: The Angeles Clinic and Research Institute

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Sociedade Beneficante de Sennores - Hospital Sino Libante

location_facility: Erasme Hospital, Free Universtiy of Brussels

location_facility: Center for Oncology Research and Treatment

location_facility: La Jolla Hematology and Oncology Medical Group

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie

location_facility: University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Biocor - Hosp. de Doencas Cardiovasculares Ltda.

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: University of Colorado Health Sciences Center

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Washington Unv. School of Med./ Siteman Cancer Center

location_facility: University of Pittsburgh Cancer Institute

location_facility: Hospital General de Agudos Carlos G. Durand

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Cancer Centre of Southeastern Ontario at KGH

location_facility: St. Luke's Cancer Center, The Royal Surrey County Hospital

location_facility: University of Debrecen, Medical and Health Sciences Center

location_facility: Centre-Hospitalier Universitaire de Saint-Etienne

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Emory University Hospital-Winship Cancer Institute

location_facility: University of Florida/Jacksonville Faculty Clinic

location_facility: Center for Cancer Care at Goshen Health System

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: North County Oncology Medical Clinical, Inc.

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.

location_facility: Centre Hospitalier Universitaire Vaudois - CHUV

location_facility: Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias

location_facility: St. Mary's Medical Center - Northern California Melanoma Center

location_facility: Indiana Oncology Hematology Consultants North


title: A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

summary: The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

ReferenceCitation: Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

ReferenceCitation: Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.

ReferenceCitation: Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.

location_country:
Croatia
Spain
Italy
United States
Belgium
Philippines
Hong Kong
Slovenia
Argentina
Indonesia
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Latvia
Estonia
Thailand
France

location_facility:
Research site
Research Site


title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

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

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

location_facility: Albany Medical Center South Clinical Campus

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Klinik Und Poliklinik für Urologie und Kinder

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: South Orange County Medical Research Center

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Klinik fur Urologie der Universitat Wien

location_facility: The Institute Of Cancer Research - Royal Marsden Hospital

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

location_facility: Clinical Research Centre - St Georges Hospital

location_facility: Urologische Klinik Und Poliklinik Grosshadern

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

location_facility: Hillcrest Urological Medical Group, Inc.

location_facility: The University Of North Carolina At Chapel Hill

location_facility: Mississippi Center For Clinical Research, LLC

location_facility: Drs. Werner, Murdock, & Francis, Pa Urology Assoc.

location_facility: Clinica Urologica I - Università di Bari

location_facility: Istituto Nazionale per la Ricerca sul Cancro -IST

location_facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

location_facility: The University Of TX SW Medical Center At Dallas

location_facility: Clinica Urologica - Università Di Milano

location_facility: University Of Washington School Of Medicine


title: PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

summary:
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.

ReferenceCitation: Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. Epub 2007 Jan 19.

ReferenceCitation: Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82.

ReferenceCitation: Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42.

ReferenceCitation: Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.

ReferenceCitation: Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.

ReferenceCitation: Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.

ReferenceCitation: Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2. Erratum in: Lancet Oncol. 2021 Jan;22(1):e5.

ReferenceCitation: Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.

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

location_country:
Poland
Bosnia and Herzegovina
Portugal
Spain
Italy
United Kingdom
Netherlands
Switzerland
France
Chile
Israel
Turkey
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Service Cancerologie Polyclinique Clairval

location_facility: Institute of Oncology - Clinical Center University of Sarajevo

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Istanbul University-Institute of Oncology

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

intervention_type: Radiation


title: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

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:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Australia
India
Israel
Turkey
Sweden
Malaysia
Brazil
Canada
China
Germany
Denmark
France
Netherlands

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

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

location_facility: The Third Xiangya Hospital, Central South University

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: M S Ramaiah Medical College and Hospital

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

location_facility: Institute of Hematology & Blood Diseases Hospital

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

location_facility: Ankara Gulhane Training and Research Hospital

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Fujian Meidical University Union Hospital

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

location_facility: Jawaharlal Institute of Postgraduate Medical Education and Research

location_facility: First Affiliated Hospital of Guangxi Medical University

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Niigata University Medical & Dental Hospital

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Bhagwan Mahaveer Cancer Hospital & Research Centre

location_facility: Shengjing Hospital of China Medical University

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Instituto Joinvilensse de Hematologia e Oncologia

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

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

location_facility: Instituto Catalan Deoncologia Hospital Duran I Reynals

location_facility: University Hospitals Birmingham NHS Foundation Trust

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

location_facility: The First Bethune Hospital of Jilin University

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Harbin medical university cancer hospital

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: First affiliated Hospital of Zhejiang University

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

status_simplified: Ongoing


status: Recruiting

title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
India
Turkey
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Washington University School of Medicine

location_facility: City of Hope Orange County Lennar Foundation Cancer Center

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: LSUHSC Shreveport Feist-Weiller Cancer Center

location_facility: M S Ramaiah Medical College and Hospital

location_facility: National Hospital Organization Mito Medical Center

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Institute of Hematology & Blood Diseases Hospital

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Second Xiangya Hospital of Central South Hospital

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Fujian Meidical University Union Hospital

location_facility: Universita Degli Studi di Roma 'Tor Vergata'

location_facility: Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

location_facility: Jawaharlal Institute of Postgraduate Medical Education and Research

location_facility: Cooper Health System MD Anderson Cancer Center at Cooper

location_facility: Tom Baker Cancer Center, University of Calgary

location_facility: First Affiliated Hospital, Medical School of Zhejiang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

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

location_facility: Barwon Health - University Hospital Geelong

location_facility: Bhagwan Mahaveer Hospital & Research Centre

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Karolinska University Hospital, Huddinge

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Shengjing Hospital of China Medical University

location_facility: SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Henry Ford Hospital - Hematology/oncology

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: University of Texas Southwestern Medical Center

summary: The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).


title: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

summary: The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in combination with pomalidomide and dexamethasone (DPd).

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Turkey
Czechia

location_facility: Washington University School of Medicine

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

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Chonnam National University Hwasun Hospital

location_facility: On Dokuz Mayıs University Medical Faculty

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Presidio Ospedaliero Santo Spirito in Sassia

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

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

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

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Hematologii

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Tongji Hospital, Tongji Medical College of HUST

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: The second Xiangya Hospital of Central South University

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: University of Massachusetts Medical School

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

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Fujian Medical University Union Hospital

location_facility: Xinqiao Hospital. Army Medical University

location_facility: National Hospital Organization Matsumoto Medical Center

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

location_facility: A.O. Universitaria Ospedali Riuniti di Ancona

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: Severance Hospital, Yonsei University Health System

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Sichuan Academy of Medical Science Sichuan Provincial People's Hospital

location_facility: University of Mississippi Medical Center

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

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

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: First Affiliated Hospital, SooChow University

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Azienda Ospedaliera Policlinico S. Orsola-Malpighi

location_facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk


title: A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

acronym: PROXYMO-ADV

summary: The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Spain
Italy
United Kingdom
United States
Peru
South Africa
Philippines
Japan
Hong Kong
Austria
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Singapore
Brazil
Canada
Switzerland
China
Germany
Taiwan
Greece
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Colombia


title: A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

acronym: OLERO

summary: This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Slovakia
Canada
Switzerland
Germany
Bulgaria
Latvia
Estonia
Finland
France

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Rutgers New Jersey Medical School; Department of Neurology

location_facility: Maritime Medicine Centre of Latvia Hospital of Vecmilgravis; Department of Neurology

location_facility: "MHAT Avis - Medica" OOD; Department of Neurology

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials

location_facility: Krajska zdravotni a.s. - Nemocnice Teplice o.z.

location_facility: Uni of Texas Health Science Center At Houston

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: CHU Nantes - Hopital Nord Laënnec; Pharmacy

location_facility: Military Medical Academy - MHAT - Sofia; Department of Rheumatology

location_facility: Vero Beach Neurology and Research Institute

location_facility: Hospital de Basurto; Servicio de Neurologia

location_facility: MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: University First MHAT-Sofia "St. Joan Krastitel" EAD

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Collaborative Neuroscience Research, LLC

location_facility: University of Alberta; Northern Alberta Trials & Research Centre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: NHI Central Clinical Hospitall of JSC Russian Railways

location_facility: Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution