RecruitingPhase 1NCT05694715

Combination Therapy in Cancers With Mutations in DNA Repair Genes

Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes

Sponsor

University of California, San Francisco

Enrollment

24 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor BRCA1 Mutation BRCA2 Mutation ATM Gene Mutation PALB2 Gene Mutation

Summary

The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA), partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators. There is significant interest in this combination, and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Irinotecan and a drug called Niraparib for people with atm gene mutation, brca1 mutation, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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