drugset / Trial / NCT02468557
Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.
Timeline
- Start
- 2015-07-30
- Primary completion
- 2016-04-27
- Completion
- 2016-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idelalisib | Small molecule | 150 mg | Oral |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Background | racemic leucovorin | Unknown | 400 mg/m2 | Intravenous |