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Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies

NCT03209401 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-02-05

No results posted yet for this 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.

Conditions

  • Solid Tumor, Adult
  • Homologous Recombination Deficiency

Interventions

DRUG

Niraparib

an oral PARP inhibitor

DRUG

Carboplatin

a platinum-based injection

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Claudine Isaacs, MD · Lombardi Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2023-10-16
Completion
2023-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209401 on ClinicalTrials.gov