Spots Global Cancer Trial Database for Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

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Trial Identification

Brief Title: Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair

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

Study ID: NCT03318445

Conditions

Solid Tumor, Unspecified, Adult

Interventions

Rucaparib

Irinotecan

Study Description

Brief 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.