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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 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 31 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02607228
The ClinicalTrials.gov registry entry for NCT02607228 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT02607228 reports 0 study locations.
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.
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