Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
- Registration Number
- NCT01427946
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- ≥18 years of age
- Voluntarily sign an informed consent form (ICF).
- Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
- Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
- Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
- ECOG performance of 0-1.
- Prior treatment with IPI-504 or other Hsp90 inhibitors.
- Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
- Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
- Inadequate hematologic function defined as:
- Inadequate hepatic function defined by:
- Inadequate renal function defined by serum creatinine >1.5 x ULN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Retaspimycin HCl (IPI-504) and Everolimus IPI-504 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. Retaspimycin HCl (IPI-504) and Everolimus 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate 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).
- Secondary Outcome Measures
Name Time Method Progression Free Survival 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 Up to three years from last patient study visit Time to progression (TTP), defined as time from study entry to progression.
Overall Survival 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.
Trial Locations
- Locations (5)
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
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Colorado Denver🇺🇸Aurora, Colorado, United States