Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

Solid Tumor, Unspecified, Adult Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Solid Tumor, Unspecified, Adult

• NCT number: NCT03318445
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2018
• Completion date: March 1, 2021