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

2014-07-23 21:08:58 | BioPortfolio

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).

Description

IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Metastatic Pancreatic Cancer

Intervention

IPI-926 plus gemcitabine, Placebo plus gemcitabine

Location

Institute of Translational Oncology Research
Greenville
South Carolina
United States
29605

Status

Recruiting

Source

Infinity Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:58-0400

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