drugset / Trial / NCT01585805

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT01585805

Phase 2 Active not recruiting 83 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well veliparib together with gemcitabine hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread from the primary site (place where it started) to other places in the body (metastatic). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. It is not yet known whether giving veliparib together with gemcitabine hydrochloride and cisplatin is an effective treatment for pancreatic cancer.

Timeline

Start
2012-05-15
Primary completion
2024-12-31
Completion
2027-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Veliparib Small molecule 20 mg Oral
Subject Veliparib Small molecule 40 mg Oral
Subject Veliparib Small molecule 80 mg Oral
Subject Veliparib Small molecule 140 mg Oral
Subject Veliparib Small molecule 200 mg Oral
Subject Veliparib Small molecule 300 mg Oral
Subject Veliparib Small molecule 400 mg Oral
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 600 mg/m2 Intravenous