drugset / Trial / NCT01130142

A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

NCT01130142

Phase 1/2 Completed 122 enrolled Infinity Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence. Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).

Timeline

Start
2010-04
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Patidegib Small molecule 160 mg Oral
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous