Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

Part of paid clinical trials in San Francisco, California.

Sponsor
Pamela Munster
Study ID
NCT03318445
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Unspecified, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    All participants will take rucaparib by mouth
  • Irinotecan — DRUG
    Patients in the dose escalation phase, and patients in the dose expansion phase who have received prior PARP inhibitor therapy, will be given irinotecan by in combination with rucaparib.

Study Details

This is an open label, non-randomized, dose escalation and expansion Phase Ib trial to evaluate the safety and recommended phase II dose of the combination of irinotecan and rucaparib.

Key Dates

Start date
Jan 12, 2018
Status verified
Mar 2021
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib and irinotecan
    Rucaparib will be taken twice daily by mouth for 7-14 days in 21 or 28 day cycles. Irinotecan will be administered by IV for 90 minutes every 14 days, or every 21 days if not tolerated. During the dose escalation phase, the maximum tolerated dose for combining Rucaparib and irinotecan will be determined. The dose for rucaparib during dose escalation will range from 300 mg to 600 mg, depending on the progression of study. The dose for irinotecan during dose escalation may range from 40 mg/m2 to 150 mg/m2. During the dose expansion phase, patients who have received prior PARP inhibitors will be given rucaparib and irinotecan at the maximum tolerated dose levels determined during the dose escalation phase.
  • Experimental: Rucaparib only
    During the dose expansion phase, patients who have not received prior PARP inhibitor therapy will take 600 mg of rucaparib by mouth daily. Patients who progress on single-agent rucaparib will be given the option to cross-over to the combination treatment arm and receive rucaparib in combination with irinotecan at the maximum tolerated dose levels determined during dose escalation.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 24 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-

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By research site
University of California San Francisco· San Francisco, CA

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