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NCT02607228 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02607228: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT02607228 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02607228, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) of alobresib as a single agent and in combination with enzalutamide, in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: * In group 1, the efficacy of alobresib as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) * In group 2, the efficacy of alobresib combined with enzalutamide in participants with mCRPC who have progressed while receiving treatment with abiraterone (may not have previously received enzalutamide) * In group 3, the efficacy of alobresib combined with enzalutamide in participants with mCRPC who have had prostate specific antigen (PSA) progression, but not radiographic progression, while receiving treatment with enzalutamide (participants may have also previously received abiraterone)
Primary Outcome
A DLT was a toxicity, considered possibly related to alobresib, and which occurred during the DLT assessment window (Days 1 through 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count (ANC) \< 500/mm\^3), Grade ≥ 3 neutropenia (ANC\< 1000/mm\^3) with fever (a single temperature \> 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour (h)), Grade ≥ 3 thrombocytopenia, Grade ≥ 2 bleeding (eg, gastrointestinal, respiratory, epistaxis, purpura), Grade ≥ 3 non hematologic
Interventions
- DRUG Enzalutamide
- DRUG Alobresib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-12-08 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 1 |
Why NCT02607228 stopped before completion
NCT02607228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT02607228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02607228 about?
NCT02607228 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer". This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) of alobresib as a single agent and in combination with enzalutamide, in participants with m...
What is the current status of trial NCT02607228?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2015-12-08. Estimated completion is 2019-09-03.
What interventions are being tested in trial NCT02607228?
The interventions under investigation include: Enzalutamide (DRUG), Alobresib (DRUG).
Who is sponsoring clinical trial NCT02607228?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02607228's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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