BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT02204072
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 836845 & Enzalutamide BI 836845 - Enzalutamide Enzalutamide - BI 836845 & Enzalutamide Enzalutamide -
- Primary Outcome Measures
Name Time Method Prostate Surface Antigen (PSA) response - defined as a decline in PSA value >50% (which is confirmed by a second value 3 to 4 weeks apart) (phase Ib expansion) Up to 3 years Maximum tolerated dose (phase Ib escalation) 6 months Number of patients with dose limiting toxicities (phase Ib escalation) 6 months Radiological Progression free survival - time from randomisation to disease progression based on investigator assessment in bone, or soft tissue, or death (phase II) Up to 3 years
- Secondary Outcome Measures
Name Time Method Maximum decline in PSA - compared to baseline that occurs at any point after treatment start (phase II) Up to 3 years Overall survival - defined as the time from randomisation to death from any cause (phase II) Up to 3 years PSA response - defined as a decline in PSA value >50%, which is confirmed by a second value 3 to 4 weeks apart (phase II) Up to 3 years Time to prostate serum antigen (PSA) progression - defined as the date that a 25% or greater increase in PSA, and an absolute increase of 2 ng/mL or more from the nadir, is documented, which is confirmed by a second value 3 or more weeks later (phase II) Up to 3 years Percentage change in PSA - from baseline to week 12 of treatment (phase II) Up to 3 years CTC response-CTC reduction compared to baseline for at least one time point after treatment start assessed by maximum change in CTC counts compared to baseline that occurs at any point after treatment start (phase II) Up to 3 years Changes in circulating tumour cells (CTC) response - CTC reduction compared to baseline for at least one time point after treatment defined as CTC decline from, equal to, or more than, 5 to <5 cells per 7.5ml blood (phase Ib expansion) Up to 3 years Changes in CTC response - CTC reduction compared to baseline for at least one time point after treatment start assessed by CTC decline from, equal to, or more than, 5 to <5 cells per 7.5ml blood (phase II) Up to 3 years Radiological progression free survival - defined as time from start of treatment to disease progression based on investigator assessment in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase Ib expansion) Up to 3 years Radiological progression free survival - defined as time from randomisation to disease progression based on central review in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase II) Up to 3 years
Trial Locations
- Locations (27)
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
The Clatterbridge Cancer Centre
🇬🇧Bebington, Wirral, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
NewYork-Presbyterian/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
The Christie Hospital
🇬🇧Manchester, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
The Royal Marsden Hospital, Sutton
🇬🇧Sutton, United Kingdom
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Erasmus MC - Daniel den Hoed
🇳🇱Rotterdam, Netherlands
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tweesteden Ziekenhuis, locatie Tilburg
🇳🇱Tilburg, Netherlands
OncoCare Cancer Centre
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong