Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
NCT ID: NCT03925350
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
41 participants
INTERVENTIONAL
2019-03-20
2023-02-28
Brief Summary
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Detailed Description
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In melanoma, genetic HR mutation/ alterations are rather common. Retrospective data showed that nearly 30.5% of cutaneous melanoma harbors a mutation in at least 1 of the HR genes in their tumor. The most commonly altered gene was ARID2, followed by ARID1A, FANCA, ATM, BRCA1, ATRX and BRCA2, ATR, BRCA1 and BRIP1.
These findings provide a strong rationale to evaluate the clinical efficacy of a PARP inhibitor in patients with advanced cancers with HR mutation/alteration or HR deficiency. Therefore, the investigators propose a phase II study of niraparib in patients with advanced melanoma with genetic homologous recombination mutation/ alteration.
In this clinical study, clinical efficacy of niraparib will be evaluated by assessing an objective clinical response rate in patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. All participating patients will receive niraparib 300 mg a day until disease progresses or they experience intolerable toxicity.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib
Patients receive niraparib PO daily
Niraparib
300 mg PO daily
Interventions
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Niraparib
300 mg PO daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Tesaro, Inc.
INDUSTRY
Vanderbilt-Ingram Cancer Center
OTHER
Huntsman Cancer Institute
OTHER
California Pacific Medical Center Research Institute
OTHER
Responsible Party
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Kevin Kim
Principal Investigator
Principal Investigators
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Kevin Kim, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Locations
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California Pacific Medical Center Research Institute
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kim KB, Desprez PY, de Semir D, Woo RWL, Sharma A, Jones R, Caressi C, Nosrati M, Janiczek E, Rivera Penafiel J, Kashani-Sabet M. Phase II Study of Niraparib in Patients With Advanced Melanoma With Homologous Recombination Pathway Gene Mutations. JCO Precis Oncol. 2025 May;9:e2400658. doi: 10.1200/PO-24-00658. Epub 2025 May 15.
Other Identifiers
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CPMC17-MEL01
Identifier Type: -
Identifier Source: org_study_id