Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung Cancer (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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
University of Colorado Denver
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
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).
Time frame: Up to three years from last patient study visit
Progression Free Survival
Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.
Time frame: Up to three years from last patient study visit
Time to Progression
Time to progression (TTP), defined as time from study entry to progression.
Time frame: Up to three years from last patient study visit
Overall Survival
Overall survival (OS), defined as time from study entry to death due to any cause, in patients with KRAS mutant NSCLC administered IPI-504 plus everolimus.
Time frame: Up to three years from last patient study visit
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Memorial Sloan Kettering Cancer Center
New York, New York, United States