NCT03318445

Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

Combination Therapy of Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pamela Munster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In dose escalation, patients will receive irinotecan and rucaparib. Irinotecan will be given once every 2 weeks (or 3 weeks if not tolerated) and rucaparib will be given twice daily for 7-14 days. Each cycle will be 28 days in duration unless we need to switch to the intermediate dosing regimen of every 21 days. Both rucaparib and irinotecan will be escalated. In dose expansion, patients who have received prior PARP inhibitors will go straight to the combination arm of irinotecan and rucaparib. If patients are PARP inhibitor naïve, they can receive single agent rucaparib until progression. Once patients on single agent rucaparib progress, they can choose to go on the combination treatment arm. Patients will continue on treatment until disease progression or intolerable toxicity.

Conditions

• Solid Tumor, Unspecified, Adult

Interventions

Type	Name	Description
DRUG	Rucaparib	All participants will take rucaparib by mouth
DRUG	Irinotecan	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.

Timeline

• Start date: 2018-01-12
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2017-10-23
• Last updated: 2021-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study