Actively Recruiting
Combination Therapy of Niraparib and Irinotecan in Cancers with DNA Repair Gene Mutations
Led by University of California, San Francisco · Updated on 2026-03-17
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and potential effectiveness of combining two cancer drugs, niraparib and irinotecan, in people with advanced solid tumors that have specific genetic mutations affecting DNA repair, such as BRCA1, BRCA2, ATM, or PALB2. This phase 1 clinical trial aims to find out if this combination treatment can be given safely with manageable side effects and to determine the best dose for future studies. The trial focuses on cancers including gastrointestinal, breast, and ovarian types, where these mutations may affect treatment response. Participants will receive niraparib orally for the first seven days of each 21-day cycle, along with irinotecan given intravenously on the first day of each cycle. Dosage levels of niraparib and irinotecan will vary depending on participant weight and toxicity observed, with groups of three to six participants receiving different dose levels. Treatment continues until unacceptable side effects, disease progression, withdrawal, or other reasons, followed by a safety follow-up for 30 days and monitoring every 12 weeks for up to two years. During the study, participants will be evaluated for safety by tracking treatment-related side effects and determining the maximum tolerated dose. Researchers will also assess how well the treatment works by measuring tumor response, disease stability, and progression-free survival over time. Participants will undergo regular visits, assessments, and tests to monitor health, side effects, and treatment effects throughout the trial and follow-up period, which may last up to two years.
CONDITIONS
Brief Title
Combination Therapy in Cancers With Mutations in DNA Repair Genes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18 years of age or older
- Ability to understand and voluntarily sign informed consent before study procedures
- Solid tumors including gastrointestinal, breast, and ovarian cancers (excluding prostate cancer) with BRCA1, BRCA2, ATM, or PALB2 mutations confirmed by testing
- At least one measurable lesion by RECIST 1.1 criteria
- Advanced solid tumor malignancy without curative options
- At least 3 weeks or 5 half-lives since last anticancer therapy, whichever is shorter
- All prior treatment toxicities recovered to less than grade 2
- ECOG Performance Status of 0 or 1 (Karnofsky > 60%)
- Adequate organ function as defined by specific blood counts and liver and kidney tests
- Able to take oral medications
- Use of highly effective contraception for participants of childbearing potential
- HIV-infected individuals with undetectable viral load on therapy are eligible
- Individuals with controlled hepatitis B or treated hepatitis C infection are eligible
You will not qualify if you...
- Significant medical conditions or lab abnormalities posing unacceptable risk
- Prior allergic reaction to PARP inhibitors or irinotecan
- Known toxicity or sensitivity to irinotecan (e.g., severe neutropenia)
- High-risk UGT1A1 gene polymorphisms related to irinotecan toxicity
- Concurrent use of other investigational agents within 3 weeks or 5 half-lives before study treatment
- Unstable brain metastases or requiring steroids for brain metastases
- Second primary malignancy
- History of posterior reversible encephalopathy syndrome (PRES)
- Uncontrolled high blood pressure
- Malabsorption syndromes or uncontrolled nausea, vomiting, or diarrhea affecting oral medication absorption
- Known or suspected myelodysplastic syndromes or acute myeloid leukemia
- Known Gilbert's disease
- Pregnancy, breastfeeding, or planning to conceive during treatment and specified follow-up
- Inability or unwillingness to comply with study procedures or use effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive combination therapy with niraparib and irinotecan in 21-day cycles. Treatment continues until unacceptable toxicity, disease progression, withdrawal of consent, start of new anti-cancer therapy, or death.
Visits on Day 1 of each 21-day cycle for irinotecan infusion and monitoring; niraparib is taken orally on Days 1-7 of each cycle
Duration - 30 days after last dose for safety monitoring, then every 12 weeks for up to 2 years
Participants are monitored for safety for 30 days after stopping treatment and then followed every 12 weeks for up to 2 years for disease progression or survival.
1 visit 30 days after treatment ends, then visits every 12 weeks for up to 2 years
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
E
Early Phase Cancer Clinical Trials Recruitment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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