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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 is a Phase 1 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03209401
The ClinicalTrials.gov registry entry for NCT03209401 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT03209401 reports 0 study locations.
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.
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