Back to resultsPhase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IPI-504
Everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring KRAS mutant, Non-Small Cell Lung Cancer, NSCLC
Eligibility Criteria
Inclusion Criteria:
- ≥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 Criteria:
- 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.
Sites / Locations
- University of Colorado Denver
- Moffitt Cancer Center
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Retaspimycin HCl (IPI-504) and Everolimus
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Progression Free Survival
Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.
Time to Progression
Time to progression (TTP), defined as time from study entry to progression.
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.
Full Information
NCT ID
NCT01427946
First Posted
August 31, 2011
Last Updated
November 12, 2014
Sponsor
Infinity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01427946
Brief Title
Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
Official Title
A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
KRAS mutant, Non-Small Cell Lung Cancer, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retaspimycin HCl (IPI-504) and Everolimus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IPI-504
Other Intervention Name(s)
retaspimycin hydrochloride
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Afinitor
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Title
Time to Progression
Description
Time to progression (TTP), defined as time from study entry to progression.
Time Frame
Up to three years from last patient study visit
Title
Overall Survival
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tess Schmalbach, MD, PhD
Organizational Affiliation
Infinity Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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