Combination Therapy for Cancers with DNA Repair Gene Mutations
This study is testing a combination of two drugs, niraparib and irinotecan, for people with metastatic (spread throughout the body) solid tumors that have specific changes (mutations) in their DNA repair genes, such as BRCA1, BRCA2, ATM, or PALB2. Niraparib is a PARP inhibitor (PARPi), which is a type of drug that can help fight cancer by targeting these DNA repair issues. Researchers want to find out if this combination is safe, what the best dose is, and if it shows any early signs of being effective. The study plans to enroll 24 participants. The current recruitment status is unclear.
- Study design
- This is an open-label (everyone knows which treatment is given), non-randomized Phase 1b study. It will enroll 24 participants in small groups to find the right dose.
- What's involved
- Participants will receive niraparib orally and irinotecan intravenously (through a vein). Treatment continues until the disease gets worse, side effects are too much, or the participant withdraws.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured for 30 days after the last dose of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Combination Therapy in Cancers With Mutations in DNA Repair Genes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Varun Monga, MBBS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Percentage of participants with treatment-emergent adverse events30 days after the last dose
The percentage of participants with treatment-emergent adverse events as classified and graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 will be reported
- Maximum Tolerated Dose (MTD)30 days after the last dose
The MTD is defined as the highest dose studied for which the observed incidence of DLT is less than 33% or occurs within at most one out of six patients treated at any given dose level.
- Percentage of participants with Dose Limiting Toxicities (DLTs)30 days after the last dose
The percentage of participants with documented dose-limiting toxicities will be reported by dose level.
- Recommended Phase 2 Dose (RP2D)Up to 2 years
The RP2D will be selected based on the evaluation of dose-limiting toxicities and adverse events measured using CTCAE v5.0.