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.
Interventional
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
No
Pedro Santabarbara, MD
Study Director
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
IPI-504-15
NCT01427946
July 2011
November 2013
Name | Location |
---|---|
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 |