Spots Global Cancer Trial Database for BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
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Trial Identification
Brief Title: BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
Official Title: A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, Versus Enzalutamide Alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone
Study ID: NCT02204072
Study Description
Brief Summary: The overall aim of the trial is to investigate the safety and anti-tumour activity of an experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide, compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients that have previously been treated and failed on docetaxel and abiraterone treatments. Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide that can be taken together. Once the MTD, or recommended phase II dose, have been determined an expansion cohort will also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose, of BI 836845 and enzalutamide determined in the phase Ib escalation phase. The randomised trial (phase II) will be an open label, parallel group study design in a 1:1 ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the MTD/recommended doses, or enzalutamide alone (Arm B). In all parts of the trial safety, anti-tumour activity will be assessed, in addition to circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and determination of Overall Survival (OS).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Karmanos Cancer Institute, Detroit, Michigan, United States
NewYork-Presbyterian/Weill Cornell Medical Center, New York, New York, United States
Oregon Health and Sciences University, Portland, Oregon, United States
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Erasmus MC - Daniel den Hoed, Rotterdam, , Netherlands
Tweesteden Ziekenhuis, locatie Tilburg, Tilburg, , Netherlands
National Cancer Centre Singapore, Singapore, , Singapore
OncoCare Cancer Centre, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
The Clatterbridge Cancer Centre, Bebington, Wirral, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
The Royal Marsden Hospital, Sutton, Sutton, , United Kingdom
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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