drugset / Trial / NCT03925350
Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
Phase 2
Unknown
41 enrolled
California Pacific Medical Center Research Institute
Huntsman Cancer Institute · collabTesaro, Inc. · collabVanderbilt-Ingram Cancer Center · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-03-20
- Primary completion
- 2022-02
- Completion
- 2023-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Niraparib | Small molecule | 300 mg | Oral |