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

Completed · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT01427946

Run by

Infinity Pharmaceuticals, Inc.

People needed

47

Starts

2011-07-01

Expected to finish

2014-10-01

Last updated by the study team

2014-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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