Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01427946|
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : November 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: IPI-504 Drug: Everolimus||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Retaspimycin HCl (IPI-504) and Everolimus
Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs.
Other Name: retaspimycin hydrochlorideDrug: Everolimus
Other Name: Afinitor
- Overall Response Rate [ Time Frame: Up to three years from last patient study visit ]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).
- Progression Free Survival [ Time Frame: Up to three years from last patient study visit ]Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.
- Time to Progression [ Time Frame: Up to three years from last patient study visit ]Time to progression (TTP), defined as time from study entry to progression.
- Overall Survival [ Time Frame: Up to three years from last patient study visit ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427946
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10017|
|Study Director:||Tess Schmalbach, MD, PhD||Infinity Pharmaceuticals, Inc.|