A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC
This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The
Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in
combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and
everolimus that can safely be given in combination. The Phase 2 portion of this study will
continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with
everolimus and compare the effect of the study drugs on tumor response and life expectancy
in patients with KRAS mutant NSCLC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Up to three years from last patient study visit
Pedro Santabarbara, MD
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Colorado Denver||Denver, Colorado 80262|
|Moffitt Cancer Center||Tampa, Florida 33612|