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NCT04019327 · ClinicalTrials.gov registry record · Phase 1
A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04019327: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04019327 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04019327, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which was determined to be 1mg talazoparib and 75mg/m² temozolomide in the Phase Ib portion of this study.
Primary Outcome
Toxicities will be classified by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).
Interventions
- DRUG Temozolomide
- DRUG Talazoparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-07-11 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 1 |
What the finished NCT04019327 record still lists
NCT04019327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT04019327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04019327 about?
NCT04019327 is a clinical study titled "A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer". The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which...
What is the current status of trial NCT04019327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-07-11. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT04019327?
The interventions under investigation include: Temozolomide (DRUG), Talazoparib (DRUG).
Who is sponsoring clinical trial NCT04019327?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04019327's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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