MedTrace Logo

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

NCT03925350 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-10-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Niraparib

300 mg PO daily

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    collaborator OTHER

  • Huntsman Cancer Institute

    collaborator OTHER

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • Kevin Kim, MD · California Pacific Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2022-02-28
Completion
2023-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03925350 on ClinicalTrials.gov