IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
105
Oral
oral placebo
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
Time frame: estimated 6 months
Comparison of Time To Progression (TTP)
\*To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time frame: estimated 6 months
Comparison of Overall Survival (OS)
To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time frame: estimated 6 months
Overall Response Rate (ORR)
To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time frame: estimated 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
(TGen) Translational Genomics Research Institute
Scottsdale, Arizona, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
...and 26 more locations