acronym: RAINBOW

title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.

ReferenceCitation: Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23.

ReferenceCitation: De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25. Erratum in: Future Oncol. 2021 Sep;17(25):3409.

ReferenceCitation: Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.

ReferenceCitation: Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.

ReferenceCitation: Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7.

ReferenceCitation: Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.

ReferenceCitation: Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Brazil
Hungary
Germany
Bulgaria
Taiwan
Estonia
Korea, Republic of
France
Chile

summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.


status: Completed

primary_purpose: Treatment

acronym: ARTEMIS Load

intervention_type: Drug

title: A Randomized, International, Multi-center, Open-label Study to Document Optimal Timing of Initiation of Dronedarone Treatment After Conversion With Loading Dose of Amiodarone in Patients With Persistent Atrial Fibrillation Requiring Conversion of AF.

study_completion_date_type: Actual

lead_sponsor: Sanofi

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brûlé L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

enrollment_type: Actual

location_country:
Taiwan
Portugal
Spain
Italy
Austria
Australia
Estonia
Finland
Netherlands
Switzerland
United Kingdom
Korea, Republic of
France
Israel
Mexico
Germany

location_facility:
Investigational Site Number 250-003
Investigational Site Number 158004
Investigational Site Number 620005
Investigational Site Number 158006
Investigational Site Number 158007
Investigational Site Number 010
Investigational Site Number 756002
Investigational Site Number 158008
Investigational Site Number 250-005
Investigational Site Number 484016
Investigational Site Number 826-007
Investigational Site Number 376002
Investigational Site Number 826-005
Investigational Site Number 724005
Investigational Site Number 158002
Investigational Site Number 250-002
Investigational Site Number 276-007
Investigational Site Number 158005
Investigational Site Number 040-005
Investigational Site Number 380-007
Investigational Site Number 528004
Investigational Site Number 246-004
Investigational Site Number 009
Investigational Site Number 724003
Investigational Site Number 005
Investigational Site Number 158001
Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 724009
Investigational Site Number 013
Investigational Site Number 724004
Investigational Site Number 003
Investigational Site Number 724008
Investigational Site Number 484008
Investigational Site Number 040-002
Investigational Site Number 276-001
Investigational Site Number 376001
Investigational Site Number 484003
Investigational Site Number 410005
Investigational Site Number 380-011
Investigational Site Number 002
Investigational Site Number 004
Investigational Site Number 276-008
Investigational Site Number 040-001
Investigational Site Number 040-003
Investigational Site Number 380-012
Investigational Site Number 008
Investigational Site Number 380-002
Investigational Site Number 484012
Investigational Site Number 724010
Investigational Site Number 006
Investigational Site Number 380-009
Investigational Site Number 484001
Investigational Site Number 826-001
Investigational Site Number 276-009
Investigational Site Number 250-010
Investigational Site Number 040-007
Investigational Site Number 380-001
Investigational Site Number 756001
Investigational Site Number 233001
Investigational Site Number 250-008
Investigational Site Number 484005
Investigational Site Number 826006
Investigational Site Number 250-007
Investigational Site Number 528002
Investigational Site Number 276-011
Investigational Site Number 276-006
Investigational Site Number 410001
Investigational Site Number 276-010
Investigational Site Number 484017
Investigational Site Number 001
Investigational Site Number 484004
Investigational Site Number 410006
Investigational Site Number 484009
Investigational Site Number 276-005
Investigational Site Number 380-004
Investigational Site Number 158009
Investigational Site Number 410004
Investigational Site Number 380-010
Investigational Site Number 246-003
Investigational Site Number 724006
Investigational Site Number 826-002
Investigational Site Number 040-006
Investigational Site Number 484002
Investigational Site Number 250-009
Investigational Site Number 380-006
Investigational Site Number 158003
Investigational Site Number 276-003
Investigational Site Number 250-006
Investigational Site Number 380-005
Investigational Site Number 246-001
Investigational Site Number 724007
Investigational Site Number 276-004
Investigational Site Number 620001
Investigational Site Number 250-004
Investigational Site Number 528003
Investigational Site Number 011
Investigational Site Number 410002
Investigational Site Number 380-003
Investigational Site Number 012
Investigational Site Number 250-001
Investigational Site Number 724002
Investigational Site Number 040-004
Investigational Site Number 484013
Investigational Site Number 724001
Investigational Site Number 246-002
Investigational Site Number 007
Investigational Site Number 276-002
Investigational Site Number 410003
Investigational Site Number 484011
Investigational Site Number 484015

summary:
Primary Objective:

- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone.

Secondary Objective:

Evaluate the rate of AF recurrences two months after randomization.
Assess the safety of the change from amiodarone to dronedarone
Assess dronedarone safety
Explore dronedarone and its active metabolite plasma level (in a subset of countries)
Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Undecided

acronym: PAOLA

title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

lead_sponsor: Novartis Pharmaceuticals

type: Registry Identifier

study_start_date_type: Actual

ReferenceCitation: Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762.

ReferenceCitation: Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A; Pasireotide C2402 Study Group. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84. doi: 10.1016/S2213-8587(14)70169-X. Epub 2014 Sep 24.

location_country:
Poland
Brazil
Romania
Saudi Arabia
Colombia
Italy
Russian Federation
Spain
Argentina
Canada
United Kingdom
United States
France
Israel
Turkey
Belgium
Norway
Germany

location_facility: Swedish Neuroscience Institute 550 17th Avenue, Suite 500

location_facility: University of Texas Southwestern Medical Center Division of Hematology/Oncolog

summary: This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.


title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes

acronym: SAVOR- TIMI 53

summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

ReferenceCitation: Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030.

ReferenceCitation: Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

ReferenceCitation: Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.

ReferenceCitation: Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjöstrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.

ReferenceCitation: Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4. Review.

ReferenceCitation: Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.

ReferenceCitation: Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.

ReferenceCitation: Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.

ReferenceCitation: Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.

ReferenceCitation: Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.

ReferenceCitation: Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum in: Circulation. 2015 Oct 13;132(15):e198.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.

ReferenceCitation: Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Peru
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Taiwan
Czech Republic
Thailand
France
Chile
Netherlands


intervention_type: Other

acronym: CORRECT

title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

lead_sponsor: Bayer

ReferenceType: result

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

ReferenceCitation: Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Yoshino T, Goldberg RM, Sargent DJ, Wagner A, Laurent D, Teufel M, Jeffers M, Grothey A, Van Cutsem E. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015 Aug;16(8):937-48. doi: 10.1016/S1470-2045(15)00138-2. Epub 2015 Jul 13.

location_country:
Brazil
Portugal
Spain
Italy
Australia
Netherlands
Argentina
Canada
Czech Republic
Switzerland
Hungary
United States
France
China
Israel
Belgium
Japan
Germany
Turkey

summary: This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC


title: Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

summary:
The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

primary_purpose: Other

ReferenceCitation: Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01(B) HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
Spain
France

intervention_type: Biological


type: Other Identifier

title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

acronym: ECLIPSE

summary:
To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

location_country:
Poland
Romania
Luxembourg
Spain
Italy
United Kingdom
Netherlands
Canada
Hungary
United States
France
Israel
Belgium
Germany

location_facility:
Investigational Site Number 616008
Investigational Site Number 840329
Investigational Site Number 840353
Investigational Site Number 840331
Investigational Site Number 840215
Investigational Site Number 276009
Investigational Site Number 840344
Investigational Site Number 380003
Investigational Site Number 840316
Investigational Site Number 616005
Investigational Site Number 376002
Investigational Site Number 724005
Investigational Site Number 840312
Investigational Site Number 528004
Investigational Site Number 528006
Investigational Site Number 724003
Investigational Site Number 826001
Investigational Site Number 840338
Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 724009
Investigational Site Number 380007
Investigational Site Number 840212
Investigational Site Number 276012
Investigational Site Number 124001
Investigational Site Number 840301
Investigational Site Number 840343
Investigational Site Number 840310
Investigational Site Number 840335
Investigational Site Number 840203
Investigational Site Number 250007
Investigational Site Number 724004
Investigational Site Number 840309
Investigational Site Number 840102
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 250001
Investigational Site Number 124006
Investigational Site Number 250005
Investigational Site Number 056004
Investigational Site Number 840218
Investigational Site Number 840336
Investigational Site Number 250003
Investigational Site Number 376001
Investigational Site Number 840104
Investigational Site Number 616002
Investigational Site Number 840323
Investigational Site Number 840202
Investigational Site Number 840351
Investigational Site Number 840210
Investigational Site Number 826002
Investigational Site Number 376003
Investigational Site Number 348003
Investigational Site Number 840220
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 840320
Investigational Site Number 724010
Investigational Site Number 840350
Investigational Site Number 276003
Investigational Site Number 616007
Investigational Site Number 840302
Investigational Site Number 840207
Investigational Site Number 442001
Investigational Site Number 840303
Investigational Site Number 276001
Investigational Site Number 840337
Investigational Site Number 840105
Investigational Site Number 840213
Investigational Site Number 840322
Investigational Site Number 840345
Investigational Site Number 840216
Investigational Site Number 124005
Investigational Site Number 840211
Investigational Site Number 840106
Investigational Site Number 826006
Investigational Site Number 840219
Investigational Site Number 840346
Investigational Site Number 840205
Investigational Site Number 250008
Investigational Site Number 380006
Investigational Site Number 276008
Investigational Site Number 616001
Investigational Site Number 840341
Investigational Site Number 840326
Investigational Site Number 276004
Investigational Site Number 348005
Investigational Site Number 840317
Investigational Site Number 616004
Investigational Site Number 642005
Investigational Site Number 840201
Investigational Site Number 642002
Investigational Site Number 724006
Investigational Site Number 840328
Investigational Site Number 840321
Investigational Site Number 840319
Investigational Site Number 642006
Investigational Site Number 124003
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Investigational Site Number 276002
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Investigational Site Number 250009
Investigational Site Number 724007
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Investigational Site Number 840208
Investigational Site Number 528003
Investigational Site Number 840327
Investigational Site Number 380001
Investigational Site Number 826005
Investigational Site Number 840204
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840314
Investigational Site Number 276010
Investigational Site Number 840315
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Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 840348
Investigational Site Number 840347
Investigational Site Number 840318
Investigational Site Number 840330
Investigational Site Number 616006
Investigational Site Number 724001
Investigational Site Number 124007
Investigational Site Number 840307
Investigational Site Number 376005
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Investigational Site Number 840101
Investigational Site Number 056001
Investigational Site Number 348001
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Investigational Site Number 840339
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Investigational Site Number 840308
Investigational Site Number 840103


title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

lead_sponsor: Pierre Fabre Dermatology

ReferenceType: background

ReferenceCitation: Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819.

ReferenceCitation: Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taïeb A, Léauté-Labrèze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

ReferenceCitation: Léauté-Labrèze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.

location_country:
Poland
Romania
Spain
Italy
Russian Federation
Australia
New Zealand
Canada
Czech Republic
Lithuania
Hungary
United States
France
Peru
Mexico
Germany

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Department of Pediatric Surgery and Oncology

location_facility: Spitalul Clinic de Urgenta pentu Copii Sf. Maria

location_facility: Klinika Onkologii, Centrum Zdrowia Dziecka

location_facility: Spitalul de Urgenta Copii, Louis Turcanu

location_facility: Servicio de Dermatologia del Hospital Infantil

location_facility: Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu

location_facility: Medical University - Filatov Pediatric Hospital

location_facility: Eastern Clinical Research Unit - Box Hill Hospital

location_facility: Hopital Robert Debre - Consultation de Dermatologie

summary: There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.


title: A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy

summary: The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.

ReferenceCitation: Durez P, Vandepapeliere P, Miranda P, Toncheva A, Berman A, Kehler T, Mociran E, Fautrel B, Mariette X, Dhellin O, Fanget B, Ouary S, Grouard-Vogel G, Boissier MC. Therapeutic vaccination with TNF-Kinoid in TNF antagonist-resistant rheumatoid arthritis: a phase II randomized, controlled clinical trial. PLoS One. 2014 Dec 17;9(12):e113465. doi: 10.1371/journal.pone.0113465. eCollection 2014.

lead_sponsor: Neovacs

location_country: Croatia Romania Argentina France Chile Belgium Bulgaria

location_facility: Universiteit ZiekenHuis Katholiek Universiteit Leuven

location_facility: Centro de Investigaciones Reumatologicas

location_facility: Universitaires Cliniques St. Luc (Mont-Godinne)

location_facility: Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802

location_facility: Centro especializado en Investigaciones Medicas (CEIM)

location_facility: National Multiprofile Transport Hospital "Tzar Boris III"

location_facility: "Sociedad Médica del Aparato Locomotor SA"

location_facility: "Dr. Constantin Opris" Emergency County Hospital Baia Mare

location_facility: University Hospital for Active Treatment "Sveti Ivan Rilski"

location_facility: Centro de Estudios Reumatológicos- Estudios Clínicos Limitada"


title: An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection

summary: The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

ReferenceCitation: Marty FM, Man CY, van der Horst C, Francois B, Garot D, Mánez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study. J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 Aug 27.

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.

location_country:
Brazil
Hong Kong
Spain
United Kingdom
Russian Federation
Australia
Canada
Thailand
United States
France
Norway
South Africa
Japan


acronym: BRIM 3

title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dréno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

ReferenceCitation: Chapman PB, Robert C, Larkin J, Haanen JB, Ribas A, Hogg D, Hamid O, Ascierto PA, Testori A, Lorigan PC, Dummer R, Sosman JA, Flaherty KT, Chang I, Coleman S, Caro I, Hauschild A, McArthur GA. Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study. Ann Oncol. 2017 Oct 1;28(10):2581-2587. doi: 10.1093/annonc/mdx339.

ReferenceCitation: Yamazaki N, Kiyohara Y, Sugaya N, Uhara H. Phase I/II study of vemurafenib in patients with unresectable or recurrent melanoma with BRAF(V) (600) mutations. J Dermatol. 2015 Jul;42(7):661-6. doi: 10.1111/1346-8138.12873. Epub 2015 Apr 17.

ReferenceCitation: Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.

ReferenceCitation: McArthur GA, Chapman PB, Robert C, Larkin J, Haanen JB, Dummer R, Ribas A, Hogg D, Hamid O, Ascierto PA, Garbe C, Testori A, Maio M, Lorigan P, Lebbé C, Jouary T, Schadendorf D, O'Day SJ, Kirkwood JM, Eggermont AM, Dréno B, Sosman JA, Flaherty KT, Yin M, Caro I, Cheng S, Trunzer K, Hauschild A. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014 Mar;15(3):323-32. doi: 10.1016/S1470-2045(14)70012-9. Epub 2014 Feb 7.

ReferenceCitation: Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.

ReferenceCitation: Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15. doi: 10.1056/NEJMoa1105358.

ReferenceCitation: Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. doi: 10.1056/NEJMoa1103782. Epub 2011 Jun 5.

location_country:
United Kingdom
Italy
Australia
Netherlands
Canada
New Zealand
Switzerland
Sweden
United States
France
Israel
Germany

summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


title: A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

lead_sponsor: Amgen

ReferenceCitation: Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.

location_country:
Serbia
Spain
Italy
United Kingdom
Romania
Belgium
Poland
Portugal
Slovenia
Russian Federation
Australia
Israel
Mexico
Slovakia
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
Czech Republic
France

summary: The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sánchez-Iglesias Á, di Capua C, Castro E, Ferrer C, Sánchez-Hernández A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6.

ReferenceCitation: Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.

ReferenceCitation: de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.

ReferenceCitation: Fizazi K, Flaig TW, Stöckle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

ReferenceCitation: Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.

ReferenceCitation: Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

ReferenceCitation: Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.

ReferenceCitation: Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

ReferenceCitation: Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.

ReferenceCitation: Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

ReferenceCitation: Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

ReferenceCitation: Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.

ReferenceCitation: Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

location_country:
Spain
Greece
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).


acronym: Sorafenib or Placebo in combination with TACE for intermediate HCC (SPACE)

title: A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

ReferenceCitation: Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22.

location_country:
Taiwan
Spain
Italy
Austria
Australia
Canada
Korea, Republic of
United States
France
China
Singapore
Belgium
Germany

location_facility: Gangnam Severance Hospital, Yonsei University

summary: This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.


acronym: CERTO

title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Chemotherapy Alone as First Line Treatment for Subjects With Advanced NSCLC

lead_sponsor: Merck KGaA, Darmstadt, Germany

ReferenceCitation: Vansteenkiste J, Barlesi F, Waller CF, Bennouna J, Gridelli C, Goekkurt E, Verhoeven D, Szczesna A, Feurer M, Milanowski J, Germonpre P, Lena H, Atanackovic D, Krzakowski M, Hicking C, Straub J, Picard M, Schuette W, O'Byrne K. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO). Ann Oncol. 2015 Aug;26(8):1734-40. doi: 10.1093/annonc/mdv219. Epub 2015 May 4.

location_country:
Poland
Spain
Ireland
Italy
Czech Republic
France
Belgium
Germany

summary:
Primary objective of the study's Safety run-in:

- To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Primary objective of the study's Randomization Part:

- To assess the efficacy of cilengitide in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.

Study design and plan:

This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in part in subjects with advanced non-small cell lung cancer (NSCLC).

During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide intravenous [i.v.] 1000 milligram [mg] to 2000 mg twice a week) in a classical 3+3 subjects (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and schedule reduction rules.

In the safety run-in 12 subjects were included and evaluated for safety and feasibility of different escalating doses of cilengitide administered twice weekly in combination with cetuximab, cisplatin and vinorelbine or gemcitabine.

After completion of the safety run-in, the randomized part will be started, during which all subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be closed with implementation of Amendment No. 4 (dated 20 December 2010):

• Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the following:

Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on Days 1 and 8 of every 3-week chemotherapy cycle, or
Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on Days 1 and 8 of every 3-week chemotherapy cycle.

The decision which of the 2 chemotherapy regimens will be applied for a given subject is at the discretion of the treating investigator.

• Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as described for Group A.

Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December 2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue to be treated as planned.

• Group C: Cetuximab and platinum-based chemotherapy as described for Group A

Chemotherapy will be given until radiographically documented progressive disease (PD) or unacceptable toxicity but for no more than 6 cycles.

Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable toxicity.

Randomization will be performed centrally using an interactive voice/web response system (IXRS). A stratified block randomization procedure will be employed using chosen first-line chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification criterion.


title: Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial

acronym: STAR

summary: Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

ReferenceCitation: Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70.

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Belarus
Spain
Greece
Italy
Netherlands
Russian Federation
United Kingdom
Czech Republic
Ukraine
Sweden
Hungary
France
Belgium
Norway
Germany
Slovakia


title: FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction (UA/NSTEMI) Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography (OASIS 8)

acronym: FUTURA/OASIS 8

summary: The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

ReferenceCitation: FUTURA/OASIS-8 Trial Group, Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, López-Sendón JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.

ReferenceCitation: Ducrocq G, Jolly S, Mehta SR, Rao SV, Patel T, Moreno R, Gao P, Steg PG. Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002044. doi: 10.1161/CIRCINTERVENTIONS.114.002044.

ReferenceCitation: Steg PG, Mehta S, Jolly S, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Chrolavicius S, Rao SV, Granger CB, Pogue J, Laing S, Yusuf S. Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.

location_country:
Poland
Brazil
Spain
Greece
Italy
Netherlands
Russian Federation
Argentina
Canada
Czech Republic
United Kingdom
Hungary
Korea, Republic of
United States
France
India
Germany
Bulgaria


title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

summary: The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

enrollment_type: Anticipated

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Poland
Czech Republic
France
South Africa
Belgium
Netherlands

location_facility: Teaching University Hospital, ORL klinika

location_facility: University Hospital Leuven, ENT Department

location_facility: University Hospital Brussels, ENT department

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi

location_facility: Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: ORL oddělení , Karlovarská krajská nemocnice a. s.

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: Centre Hospitalier de Bretagne Sud Service

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

location_facility: ORL oddělení, Karlovarská krajská nemocncie a.s.


title: A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity

summary: The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
El Salvador
France
Belgium
Germany

location_facility: 1246.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49011 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32008 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49010 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49008 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44013 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3303A Boehringer Ingelheim Investigational Site


title: A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.

summary: The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire

status: Withdrawn

location_country:
Germany
United States
France

location_facility: 1219.4.49006 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3301A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01007 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3302A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3308A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01006 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3303A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01008 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305A Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

summary: The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

lead_sponsor: Biogen

location_country:
Poland
Brazil
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Czech Republic
Finland
Sweden
United States
France
India
Israel
Romania
Germany
Bulgaria


title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

ReferenceCitation: Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

ReferenceCitation: Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

ReferenceCitation: Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

ReferenceCitation: Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Müllhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

lead_sponsor: Tibotec BVBA

location_country:
Poland
Brazil
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
Switzerland
Sweden
Puerto Rico
United States
France
Israel
Belgium
Germany


acronym: TAURUS

title: A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder

ReferenceCitation: Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.

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

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Iceland
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Norway
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Belarus
Ireland
Latvia
Finland
France
Netherlands

summary: The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.


title: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures

acronym: ELEVATE

summary: The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

status: Terminated

ReferenceCitation: Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D; ELEVATE Study Group. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Argentina
Canada
Korea, Republic of
United States
France
India
Belgium
Pakistan


title: AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

lead_sponsor: Pfizer

ReferenceCitation: Murphy DA, Rini BI, Escudier B, Motzer RJ, Wang P, Li S, Williams JA, Tarazi JC, Martini JF. Angiogenic and immunomodulatory biomarkers in axitinib-treated patients with advanced renal cell carcinoma. Future Oncol. 2020 Jun;16(17):1199-1210. doi: 10.2217/fon-2020-0212. Epub 2020 May 4.

ReferenceCitation: Bracarda S, Bamias A, Casper J, Negrier S, Sella A, Staehler M, Tarazi J, Felici A, Rosbrook B, Jardinaud-Lopez M, Escudier B. Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial. Clin Genitourin Cancer. 2019 Jun;17(3):e689-e703. doi: 10.1016/j.clgc.2019.03.017. Epub 2019 Apr 1.

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Grünwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

ReferenceCitation: Escudier B, Michaelson MD, Motzer RJ, Hutson TE, Clark JI, Lim HY, Porfiri E, Zalewski P, Kannourakis G, Staehler M, Tarazi J, Rosbrook B, Cisar L, Hariharan S, Kim S, Rini BI. Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial. Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.

ReferenceCitation: Ueda T, Uemura H, Tomita Y, Tsukamoto T, Kanayama H, Shinohara N, Tarazi J, Chen C, Kim S, Ozono S, Naito S, Akaza H. Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol. 2013 Jun;43(6):616-28. doi: 10.1093/jjco/hyt054. Epub 2013 Apr 28.

ReferenceCitation: Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16. Erratum in: Lancet Oncol. 2013 Jun;14(7):e254.

ReferenceCitation: Cella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer. 2013 Apr 30;108(8):1571-8. doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.

ReferenceCitation: Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4. Erratum in: Lancet. 2012 Nov 24;380(9856):1818.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Austria
Australia
Russian Federation
India
Sweden
Singapore
Slovakia
Brazil
Canada
China
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France

location_facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien

location_facility: Department of Oncology, National Taiwan University Hospital

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: University of Miami Hospital and Clinics

location_facility: UOC Oncologia Medica B, IRCCS AO Universitaria San Martino

location_facility: UO di Oncologia ed Ematologia, Istituto Clinico Humanitas

location_facility: Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Vanderbilt-Ingram Cancer Center-Cool Springs

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology

location_facility: Bhagwan Mahaveer Cancer Hospital and Research Center

location_facility: US Oncology Research and Clinical Pharmacy

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

location_facility: Chattanooga Oncology and Hematology Associates, PC

location_facility: Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

location_facility: University Department of Medical Oncology/Oxford Cancer Centre

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Dipartimento dei laboratori diagnositici e per le terapie cellulari

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Chattanooga Oncology Hematology Associates P.C.

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie

location_facility: University of Minnesota Medical Center Fairview

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.

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

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: Raleigh Hematology Oncology Associates, P.C.

location_facility: Taichung Veterans General Hospital, Department of Surgery

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS

location_facility: RSM Durham Regional Cancer Centre Lakeridge Health Oshawa

location_facility: Loyola University Chicago Cardinal Bernardin Cancer Center

location_facility: Chattanooga Oncology & Hematology Associates

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen

location_facility: Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie

location_facility: Tokyo Women's Medical University Hospital

location_facility: Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

location_facility: Cancer Research Center named after N.N. Blokhin, Biotherapy Department

location_facility: Tianjin Oncology Hospital,biology treatment department

location_facility: St. John's Mercy, David C. Pratt Cancer Center

location_facility: Raleigh Hematology Oncology Associates, DBA

location_facility: The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital

location_facility: National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer

location_facility: Virginia Mason Medical Center, Section of Hematology/Oncology

location_facility: Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology

location_facility: Heidelberg Repatriation Hospital, Austin Health

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica

location_facility: Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

location_facility: Hematology and Oncology Associates of SC, LLC - Eastside Medical Center

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc

location_facility: UOC Oncologia Medica, Ospedale San Donato

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

location_facility: Moscow Research Institute of Oncology P.A. Herzen

location_facility: Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center

location_facility: Universitaets-Klinik fuer Innere Medizin I

location_facility: Lake University - Ireland Cancer Center (LUICC)

location_facility: Sapporo Medical University School of Medicine

location_facility: Georgetown University Hospital, Lombardi Cancer Center

location_facility: Russian Research Center of Roentgenology and Radiology

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: British Columbia Cancer Agency - Cancer Centre for the Southern Interior

location_facility: University of Miami Sylvester at Deerfield Beach

location_facility: Klinika Urologii i Onkologii Urologicznej

location_facility: Ballarat Oncology & Haematology Services

location_facility: Institut Catala D'Oncologia L'Hospitalet

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

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

location_facility: Alexandra University Hospital / Oncology Dept.

location_facility: University of Birmingham, CRUK Institute for Cancer Studies

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

location_facility: Royal Marsden Hospital NHS Foundation Trust

location_facility: Tokyo Women's Medical University Medical Center East, Department of Urology

location_facility: Department of Medical Oncology, St. Bartholomew's Hospital

location_facility: Dept. of Medical Oncology, Tata Memorial Hospital

location_facility: Brian LeBerthon, MD, A Medical Corporation

location_facility: "Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: University of Colorado Denver: Division of Medical Oncology

location_facility: Unita' Operativa Oncologia Medica 2, Regione del Veneto

location_facility: The Cancer Center at Hackensack University Medical Center - The Hillcrest Building

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Struttura Complessa di Oncologia Medica A

location_facility: The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation

location_facility: East Valley Hematology and Oncology Medical Group

location_facility: Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano

location_facility: Agajanian Institute of Oncology and Hematology

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Cancer Research Center named after N.N.Blokhin, Chemotherapy Department

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

location_facility: Klinikum Region Hannover Krankenhaus Siloah

summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.


title: A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.

acronym: DRIVER

summary: The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will again evaluate, after 2 months of treatment if the subject wants to increase the dosage from 10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg or 5 mg. It will not be possible after this point to increase or decrease the dosage for the rest of the study. The subject will be asked to attend the clinic on four separate occasions over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor will ask the subject about their medical history, and the subject will be given a medical examination (including your heart rate, blood pressure and weight). The medical examination will also include an ECG. The subject will be asked to provide a blood and urine sample, which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their mood and feelings. The subject qualifies, they will have an interview with a trained mental health care provider who will assess their level of depression. At the end of the visit, the doctor will provide the subject with a diary in which they must record details about their attempts at sexual activity during the next 4 weeks. The subject will be asked to make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in different questionnaires about their sexuality, mood and feelings, general quality of life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples will be collected. An interview with the trained mental health care provider who will re-assess their level of depression. At this visit all information collected so far will be assessed and the doctor will check to see if the requirements to enter the treatment period are fulfilled. The subject may be excluded from further participation in the study, for example due to results of the blood analysis or if your level of depression did not meet the criteria for the study. If the subject is able to participate to the study they will be given the study drug. At each visit, adverse events will be discussed and whether there is any change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or Premature Termination. At every visit the subject will receive a diary in which they must record details about their attempts at sexual activity during the period between each visit and the number of tablets taken. Subjects will also be asked to fill in different questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity. Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study medication, 24 hours after the last dose of study medication. The doctor will give the study drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the subject will be required to return to the clinic for a physical examination, vital signs and have blood samples and ECG obtained. They will also be asked to fill in different questionnaires.

location_country:
Spain
Italy
Canada
United States
France


title: An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

ReferenceCitation: Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.

ReferenceCitation: Ferrari A, Merks JHM, Chisholm JC, Orbach D, Brennan B, Gallego S, van Noesel MM, McHugh K, van Rijn RR, Gaze MN, Martelli H, Bergeron C, Corradini N, Minard-Colin V, Bisogno G, Geoerger B, Caron HN, De Salvo GL, Casanova M. Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy. Eur J Cancer. 2020 May;130:72-80. doi: 10.1016/j.ejca.2020.01.029. Epub 2020 Mar 13.

ReferenceCitation: Chisholm JC, Merks JHM, Casanova M, Bisogno G, Orbach D, Gentet JC, Thomassin-Defachelles AS, Chastagner P, Lowis S, Ronghe M, McHugh K, van Rijn RR, Hilton M, Bachir J, Fürst-Recktenwald S, Geoerger B, Oberlin O; European paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortium. Open-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study). Eur J Cancer. 2017 Sep;83:177-184. doi: 10.1016/j.ejca.2017.06.015. Epub 2017 Aug 23.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
France
Chile
Israel
Belgium
Germany
Czechia

location_facility: CHU Bordeaux; Unite Onco-Hematologie Pediatrique

location_facility: Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica

location_facility: Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej

location_facility: Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic

location_facility: CHU Hopital Sud; Service d'Hematologie Pediatrique

location_facility: Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie

location_facility: U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer

location_facility: Birmingham Childrens Hospital; Oncology Dept

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Chr De Nantes; Service D'oncologie Pediatrique

location_facility: Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie

location_facility: University Hospital Queens Medical Centre; Department of Paediatric Oncology

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Hopital Des Enfants; Service d Hemato-Oncologie

location_facility: ITACI - Instituto de Tratamento do Cancer Infantil

location_facility: Emma Kinderziekenhuis; Dept of Pediatric Oncology

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: University Hospital Essen; Department of Pediatric Oncology

location_facility: Center for Children's Hematology, Oncology and Immunology

location_facility: Rambam Health Care Campus; Pediatric Hematology Oncology Department

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica

location_facility: Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

location_facility: CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

location_facility: St. James's University Hospital; Leeds Regional Paediatric Oncology Unit

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Hospital Infantil Universitario Nino Jesus

summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.


acronym: VIEW 2

title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

ReferenceCitation: Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. Erratum in: Ophthalmology. 2013 Jan;120(1):209-10.

ReferenceCitation: Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.

ReferenceCitation: Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.

ReferenceCitation: Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

ReferenceCitation: Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Poland
Portugal
Austria
Australia
Argentina
India
Israel
Mexico
Singapore
Sweden
Slovakia
Brazil
Switzerland
Hungary
Germany
Latvia
Czech Republic
Korea, Republic of
France
Colombia
Netherlands

summary: This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.