Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |