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NCT02204072 · ClinicalTrials.gov registry record · Phase 1
BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
A Phase 1 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT02204072: Completed Phase 1 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Boehringer Ingelheim.
NCT02204072 is a Phase 1 study of Prostatic Neoplasms, Castration-Resistant that has completed, run by Boehringer Ingelheim. The registered enrollment target is 120 participants, below the 729-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02204072, a Phase 1 study of Prostatic Neoplasms, Castration-Resistant, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Number of patients with DLTs were used to determine the maximum tolerated dose (MTD) in the Phase Ib escalation part. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.
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 |
What the finished NCT02204072 record still lists
NCT02204072 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 729-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (84% lower).
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.
NCT02204072 names 20 study sites across 4 states, led by Other, Michigan, New York.
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.
What interventions are being tested in trial NCT02204072?
The interventions under investigation include: Enzalutamide (DRUG), BI 836845 (DRUG).
Who is sponsoring clinical trial NCT02204072?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02204072's enrollment target sits among peer trials
120 7th of 10 higher than 4 of 10 other Prostatic Neoplasms, Castration-Resistant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms, Castration-Resistant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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