1280.8 - BI 836845 in metastatic castration resistant prostate cancer
Research type
Research Study
Full title
A Phase Ib/II, Multicentre, Open Label, Randomised 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
IRAS ID
157354
Contact name
Johann de Bono
Contact email
Eudract number
2013-004011-41
Duration of Study in the UK
3 years, 2 months, 11 days
Research 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 doses, have been determined an expansion cohort will also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and that are failing on this treatment as shown by a rise in prostate serum antigen (PSA) levels. Patients may, or may not, have received prior docetaxel in any setting, but must not have received abiraterone. Patients in this cohort will receive the MTD, or recommended doses, 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; pain score by Brief Pain Inventory - Short Form (BPI-SF); skeletal related events, pharmacokinetics (PK); biomarkers in blood and tissue; Pharmacogenomics (PGx) in blood and tumour tissue will be explored only in the expansion and phase II parts of the trial.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1151
Date of REC Opinion
14 Aug 2014
REC opinion
Further Information Favourable Opinion