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BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
NCT02204072 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG BI 836845
Study Locations (20)
Other
- Prince of Wales Hospital — Hong Kong
- Queen Mary Hospital — Hong Kong
- Erasmus MC - Daniel den Hoed — Rotterdam
- Tweesteden Ziekenhuis, locatie Tilburg — Tilburg
- National Cancer Centre Singapore — Singapore
- OncoCare Cancer Centre — Singapore
- Tan Tock Seng Hospital — Singapore
- Samsung Medical Center — Seoul
- Asan Medical Center — Seoul
- Hospital Vall d'Hebron — Barcelona
- Hospital Clínic de Barcelona — Barcelona
- Hospital Santa Creu i Sant Pau — Barcelona
- Hospital Duran i Reynals — L'Hospitalet de Llobregat
- Hospital General Universitario Gregorio Marañón — Madrid
- Hospital Ramón y Cajal — Madrid
- Instituto Valenciano de Oncología — Valencia
- Taichung Veterans General Hospital — Taichung
Michigan
- Karmanos Cancer Institute — Detroit
New York
- NewYork-Presbyterian/Weill Cornell Medical Center — New York
Oregon
- Oregon Health and Sciences University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2014-11-11 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02204072
The ClinicalTrials.gov registry entry for NCT02204072 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 2 interventions — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02204072 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02204072 about?
NCT02204072 is a clinical study titled "BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)". 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 treat...
What is the current status of trial NCT02204072?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2014-11-11. Estimated completion is 2023-06-01.
What conditions does trial NCT02204072 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02204072?
The interventions under investigation include: Enzalutamide (DRUG), BI 836845 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02204072?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02204072 being conducted?
This trial has 20 study locations across Michigan, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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