Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
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|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 hydrochloride
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|