drugset / Trial / NCT02890355

FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

NCT02890355

Phase 2 Completed 123 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.

Timeline

Start
2016-10-27
Primary completion
2019-05-01
Completion
2021-10-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Veliparib Small molecule Oral
Background Irinotecan Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Comparator fluorouracil Small molecule Intravenous