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NCT04598321 · ClinicalTrials.gov registry record · Phase 1
BrUOG 390: Neoadjuvant Treatment With Talazoparib
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04598321: Clinical Trial Phase 1 study, sponsored by Brown University.
NCT04598321 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04598321, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Ovarian cancer is the most fatal gynecologic cancer; in the US alone an estimated 22,000 women will be diagnosed in 2019, with over 13,000 dying of the disease. Approximately half of epithelial ovarian cancers (EOC) exhibit defective DNA repair through alterations in the homologous recombination (HR) pathway, with 14% accounted for by germline mutations in BRCA genes (mBRCA); this goes up to about one in five (20%) women when one includes tumor-associated (somatic) mBRCA.The approach to women with mBRCA-associated ovarian cancer has heralded precision treatment in our field with the availability of PARP inhibitors. Now indicated as treatment for women with documented mBRCA (genomic or somatic), it also has shown significant benefits for women with recurrent EOC who respond to platinum-based therapy when administered as maintenance treatment.
Primary Outcome
Define the proportion of volunteers completing the planned 9 weeks of treatment without disease progression.
Interventions
- DRUG Talazoparib Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2022-12-06 |
| Phase | Phase 1 |
Why NCT04598321 stopped before completion
NCT04598321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Talazoparib Oral Capsule is the first listed.
NCT04598321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04598321 about?
NCT04598321 is a clinical study titled "BrUOG 390: Neoadjuvant Treatment With Talazoparib". Ovarian cancer is the most fatal gynecologic cancer; in the US alone an estimated 22,000 women will be diagnosed in 2019, with over 13,000 dying of the disease. Approximately half of epithelial ovarian cancers (EOC) exhibit defective DNA repair through alterations in the homologous recombination (HR...
What is the current status of trial NCT04598321?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-03-29. Estimated completion is 2022-12-06.
What interventions are being tested in trial NCT04598321?
The interventions under investigation include: Talazoparib Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT04598321?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04598321's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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