Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
NCT ID: NCT01427946
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2011-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
IPI-504
Everolimus
Interventions
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IPI-504
Everolimus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Voluntarily sign an informed consent form (ICF).
3. Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
4. Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
5. Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
6. ECOG performance of 0-1.
Exclusion Criteria
2. Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
3. Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
4. Inadequate hematologic function defined as:
5. Inadequate hepatic function defined by:
6. Inadequate renal function defined by serum creatinine \>1.5 x ULN.
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tess Schmalbach, MD, PhD
Role: STUDY_DIRECTOR
Infinity Pharmaceuticals, Inc.
Locations
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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
Countries
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Other Identifiers
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IPI-504-15
Identifier Type: -
Identifier Source: org_study_id