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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Georgetown University
Study ID
NCT03209401
Phase
PHASE1
Status
Terminated

Conditions

  • Homologous Recombination Deficiency
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    an oral PARP inhibitor
  • Carboplatin — DRUG
    a platinum-based injection

Study Details

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.

Key Dates

Start date
Oct 13, 2017
Status verified
Feb 2024
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib and Carboplatin
    Niraparib will be administered orally, once daily for 21 days of each 21-day cycle in escalating doses depending on cohort patient is assigned to. Carboplatin will be administered via an injection on Day 2 of a given 21-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.

Primary Outcome Measure

Grade 3 and 4 toxicities [ Time Frame: 36 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale University, Yale Cancer CenterNew HavenConnecticut06520-
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20057-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Levine Cancer InstituteCharlotteNorth Carolina28204-

Find similar trials in New Haven, CT

By research site
Yale University, Yale Cancer Center· New Haven, CTLombardi Comprehensive Cancer Center· Washington D.C., DCSibley Memorial Hospital· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJLevine Cancer Institute· Charlotte, NC

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