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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival (PFS)
To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo. Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma
estimated 6 months
Yes
Pedro Santabarbara, MD
Study Chair
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
IPI-926-04
NCT01310816
February 2011
September 2013
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
OHSU Knight Cancer Institute | Portland, Oregon 97239 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Columbia University Medical Center | New York, New York 10032 |
Sarcoma Oncology Center | Santa Monica, California 90403 |
Washington University in St. Louis | St. Louis, Missouri 63110 |
University of Miami - Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
(TGen) Translational Genomics Research Institute | Scottsdale, Arizona 85258 |
University of Washington - Seattle Cancer Care Alliance | Seattle, Washington 98109 |