NCT01310816

A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Infinity Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.

Detailed description

Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.

Conditions

• Conventional Chondrosarcoma

Interventions

Type	Name	Description
DRUG	IPI-926	Oral
DRUG	Placebo Arm	oral placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2011-03-09
• Last updated: 2013-12-05

Locations

36 sites across 13 countries: United States, Australia, Austria, Canada, France, Germany, Italy, Netherlands, Norway, Poland, Russia, Sweden, United Kingdom