drugset / Trial / NCT02468557

Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma

NCT02468557

Phase 1 Terminated 16 enrolled Gilead Sciences
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

EvaluationDrugModalityDoseRoute
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