Recruiting
Phase 2

Niraparib

Sponsor:

California Pacific Medical Center Research Institute

Code:

NCT03925350

Conditions

Metastatic Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Niraparib

Study Details

Brief 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

Metastatic Melanoma

Study ID

NCT03925350

Start date

Mar 20, 2019

Status verified date

Oct, 2021

Completion date

Feb, 2023

Anticipated

Primary completion date

Feb, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have genetic homologous recombination (HR) mutation/ alteration including ARID1A/B, ARID2, ATM, ATR, ATRX, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B
  • Disease must have progressed on the standard systemic therapies or they could not have tolerated the standard therapies.
  • ECOG PS >/=1
  • Have measurable metastatic disease according to RECIST 1.1
  • Prior systemic cytotoxic therapy up to 1 regimens is allowed; There is no limit on the number of prior immunotherapy or targeted therapy regimens.
  • All adverse events associated with prior treatment must have resolved to ≤ Grade 1 prior to day 1 of the study drug administration.

Exclusion Criteria:

  • Previously treated with a PARP inhibitor
  • Symptomatic brain metastasis or active brain lesions ≥6 mm size or those
  • Require steroid treatment for brain lesions or leptomeningeal disease
  • Systemic cancer therapy within 14 days prior to day 1 of the study drug administration
  • Any major surgery ≤ 3 weeks of starting the study and patient must have recovered from any effects of any major surgery
  • Investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational
  • Prior radiotherapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy
  • Medical history of immunocompromised condition
  • Systemic treatment of another type of cancer ≤ 2 years prior to registration
  • Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Study Design

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Niraparib

Patients receive niraparib PO daily

Interventions

Niraparib

300 mg PO daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Emilia Janiczek

415-600-1544janicze@sutterhealth.org

Locations

California Pacific Medical Center Research Institute

Recruiting

San Francisco, California, United States, 94115

Contacts

Emilia Janiczek

415-600-1544janicze@sutterhealth.org

More Information

Sponsor

California Pacific Medical Center Research Institute

Last update posted

Oct 22, 2021

Last verified

Oct, 2021

Keywords

  • Homologous recombination (HR)
  • Mutation
  • Niraparib
  • PARP inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by California Pacific Medical Center Research Institute on 2021-10-22.