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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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

Detailed Summary: 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.
Sponsor: Infinity Pharmaceuticals, Inc.

Current Primary Outcome: Progression Free Survival (PFS) [ Time Frame: estimated 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Comparison of Time To Progression (TTP) [ Time Frame: estimated 6 months ]
  *To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
• Comparison of Overall Survival (OS) [ Time Frame: estimated 6 months ]
  To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
• Overall Response Rate (ORR) [ Time Frame: estimated 6 months ]
  To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo

Original Secondary Outcome: Same as current

Information By: Infinity Pharmaceuticals, Inc.

Dates:
Date Received: March 3, 2011
Date Started: February 2011
Date Completion:
Last Updated: December 4, 2013
Last Verified: December 2013