Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01427946 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-230

 

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).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Rebecca Heist, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: 1. ≥18 years of age 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: 1. Prior treatment with IPI-504 or other Hsp90 inhibitors. 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.
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