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A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome 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).

Outcome Time Frame:

Up to three years from last patient study visit

Safety Issue:


Principal Investigator

Pedro Santabarbara, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

November 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • KRAS mutant
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Colorado Denver Denver, Colorado  80262
Moffitt Cancer Center Tampa, Florida  33612