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Topoisomerase I inhibitor
Niraparib + Irinotecan for Breast Cancer
Phase 1
Recruiting
Led By Pamela Munster, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests safety & efficacy of a drug to treat breast, ovarian, pancreatic, prostate & melanoma cancers caused by defective gene mutations. Preclinical studies suggest it may work as a chemopotentiator.
Who is the study for?
Adults with advanced solid tumors that can't be cured and have specific DNA repair gene mutations (BRCA1, BRCA2, ATM, PALB2) are eligible. They should not have had cancer treatment recently and must be in good physical condition with well-functioning organs. Pregnant women or those who may become pregnant must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of niraparib, a drug targeting enzymes involved in DNA repair, with irinotecan, a chemotherapy agent. The goal is to see if this combo is safe and works against cancers due to faulty DNA repair genes.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Niraparib might also cause issues like high blood pressure or heart palpitations; irinotecan could lead to diarrhea or weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Percentage of participants with Dose Limiting Toxicities (DLTs)
Percentage of participants with treatment-emergent adverse events
+1 moreSecondary outcome measures
Duration of overall response (DOR)
Median Progression-Free Survival (PFS)
Median duration of stable disease (SD)
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 4b (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants weighing >= 77 kg will receive a starting dose of 300 mg of niraparib on days 1-7 each 21-day cycle, and 150 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Group II: Cohort 4a (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants weighing < 77 kg will receive a starting dose of 200 mg of niraparib on days 1-7 each 21-day cycle, and 150 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Group III: Cohort 3b (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants weighing >= 77 kg will receive a starting dose of 300 mg of niraparib on days 1-7 each 21-day cycle, and 100 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Group IV: Cohort 3a (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants weighing < 77 kg will receive a starting dose of 200 mg of niraparib on days 1-7 each 21-day cycle, and 100 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Group V: Cohort 2 (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants will receive a starting dose of 200 mg of niraparib on days 1-7 each 21-day cycle, and 100 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Group VI: Cohort 1 (Niraparib, Irinotecan)Experimental Treatment2 Interventions
Participants will receive a starting dose of 100 mg of niraparib on days 1-7 each 21-day cycle, and 100 mg/m^2 of irinotecan on day 1 of each 21 day cycle until unacceptable toxicity, disease progression or participant withdrawal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,551 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,811 Total Patients Enrolled
Pamela Munster, MDPrincipal InvestigatorUniversity of California, San Francisco
12 Previous Clinical Trials
463 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 3 weeks or 5 half-lives since my last cancer treatment.I am allergic to PARP inhibitors or irinotecan.I have a genetic variation that increases my risk of side effects from irinotecan.I have been diagnosed with Gilbert's syndrome.My cancer type responds to specific drugs, and I have certain genetic mutations.I am 18 years old or older.My cancer is advanced and cannot be cured with current treatments.I am mostly active and can carry out light work.I am using effective birth control while on niraparib/irinotecan and for 6 months (women) or 3 months (men) after.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but have been treated and cured.I have been diagnosed with or suspected to have MDS or AML.My brain metastases are stable, treated, and I'm not on steroids for them.I can understand and am willing to sign the consent form and follow the study's requirements.I have had PRES in the past.It's been 3 weeks since my last experimental treatment and any side effects are mild.I have been diagnosed with more than one type of cancer.My blood pressure is high and not well-controlled.My blood counts and liver/kidney functions are within safe ranges, and I can take pills.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4a (Niraparib, Irinotecan)
- Group 2: Cohort 4b (Niraparib, Irinotecan)
- Group 3: Cohort 1 (Niraparib, Irinotecan)
- Group 4: Cohort 2 (Niraparib, Irinotecan)
- Group 5: Cohort 3a (Niraparib, Irinotecan)
- Group 6: Cohort 3b (Niraparib, Irinotecan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA status of Cohort 1 (Niraparib, Irinotecan)?
"Due to its status as a Phase 1 trial, Cohort 1 (Niraparib, Irinotecan) was given an estimation of safety at level 1 due to the low amount of data illustrating efficacy and safety."
Answered by AI
Are there any available openings to join this scientific endeavor?
"As reflected on clinicaltrials.gov, this research project is not currently seeking participants as it was last updated on December 1st 2023; however 84 other trials are accepting patients at the present time. The trial initially went online April 1st 2023."
Answered by AI
What is the principal purpose of this clinical investigation?
"This trial will be monitored for 30 days after the last dose to identify its Maximum Tolerable Dose (MTD). Secondary objectives include quantifying overall response duration (ORD), median period of stable disease (MSD) and progression-free survival time (PFS). ORD is calculated from when a complete or partial response is first recorded until the point at which progressive disease has been objectively documented. MSD measures how long patients remain in a state of stability, while PFS tracks time from treatment initiation to either recurrence/progression or death."
Answered by AI
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