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NCT03209401 · ClinicalTrials.gov registry record · Phase 1
Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies
A Phase 1 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03209401: Clinical Trial Phase 1 study, sponsored by Georgetown University.
NCT03209401 is a Phase 1 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03209401, a Phase 1 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway (HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Primary Outcome
Phase Ia Primary Endpoint - The number of grade 3 and 4 toxicities according to NCI CTCAE; Version 4.0 that occur after Cycle 1, Day 1 will be recorded at each study visit.
Interventions
- DRUG Carboplatin
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 1 |
Why NCT03209401 stopped before completion
NCT03209401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT03209401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03209401 about?
NCT03209401 is a clinical study titled "Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies". This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway (HR deficient). The trial i...
What is the current status of trial NCT03209401?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2017-10-13. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT03209401?
The interventions under investigation include: Carboplatin (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT03209401?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03209401's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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