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NCT03944902 · ClinicalTrials.gov registry record · Phase 1
CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03944902: Clinical Trial Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT03944902 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. 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
NCT03944902, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this protocol is to investigate the efficacy of the combination of CB-839 with Niraparib in platinum resistant BRCA wild-type ovarian cancer patients. The primary and secondary objectives are to determine the maximum tolerated dose of CB-839 in combination with Niraparib and to determine the response rate and percentage of participants who remain progression free at 6 months.
Primary Outcome
Any CTCAE v4.0 grade 3 except with some identified exceptions: Grade 3-4 nausea, vomiting and diarrhea, Grade 3 transaminitis present for \<= 7 days, Grade 3 laboratory abnormalities (correctable \& asymptomatic), Grade 3 ALT or AST elevation, Grade 3 thrombocytopenia or neutropenia, and Grade 4 anemia.
Interventions
- DRUG Cohort 1: Dose Escalation
- DRUG Cohort 2: Dose Escalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2022-01-05 |
| Phase | Phase 1 |
Why NCT03944902 stopped before completion
NCT03944902 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 2 interventions - of which Cohort 1: Dose Escalation is the first listed.
NCT03944902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03944902 about?
NCT03944902 is a clinical study titled "CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients". The purpose of this protocol is to investigate the efficacy of the combination of CB-839 with Niraparib in platinum resistant BRCA wild-type ovarian cancer patients. The primary and secondary objectives are to determine the maximum tolerated dose of CB-839 in combination with Niraparib and to determ...
What is the current status of trial NCT03944902?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-09-01. Estimated completion is 2022-01-05.
What interventions are being tested in trial NCT03944902?
The interventions under investigation include: Cohort 1: Dose Escalation (DRUG), Cohort 2: Dose Escalation (DRUG).
Who is sponsoring clinical trial NCT03944902?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03944902'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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