Status:
COMPLETED
Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
Lead Sponsor:
Infinity Pharmaceuticals, Inc.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 e...
Eligibility Criteria
Inclusion
- ≥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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01427946
Start Date
July 1 2011
End Date
October 1 2014
Last Update
November 13 2014
Active Locations (5)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215