Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Part of paid clinical trials in San Francisco, California.

Sponsor
California Pacific Medical Center Research Institute
Study ID
NCT03925350
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

This open-label phase II trial studies how well niraparib works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The trial is designed to assess the efficacy and safety of niraparib in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy.

Key Dates

Start date
Mar 20, 2019
Status verified
Oct 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2023

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    Patients receive niraparib PO daily

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
California Pacific Medical Center Research InstituteSan FranciscoCalifornia94115
Emilia Janiczek
[email protected]
415-600-1544

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
California Pacific Medical Center Research Institute· San Francisco, CA

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