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NCT03586661 · ClinicalTrials.gov registry record · Phase 1
Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT03586661: Active Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03586661 is a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03586661, a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial studies the best dose and side effects of niraparib and copanlisib in treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back. Niraparib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Defined as the highest dose for which the posterior probability of toxicity is closest to 30%. Will employ the Bayesian optimal interval design. We will report the posterior probability of dose limiting toxicities (DLT) for each dose level and a 90% credible interval for the probability of DLT at each dose level.
Conditions Studied
Interventions
- DRUG Niraparib
- DRUG Copanlisib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03586661 still lists
NCT03586661 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 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (75% lower).
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Niraparib is the first listed.
NCT03586661 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03586661 about?
NCT03586661 is a clinical study titled "Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". This phase Ib trial studies the best dose and side effects of niraparib and copanlisib in treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back. Niraparib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed f...
What is the current status of trial NCT03586661?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2019-04-29. Estimated completion is 2026-12-31.
What conditions does trial NCT03586661 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Endometrial Carcinoma, Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma.
What interventions are being tested in trial NCT03586661?
The interventions under investigation include: Niraparib (DRUG), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT03586661?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03586661 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03586661's enrollment target sits among peer trials
31 28th of 39 higher than 11 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma 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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