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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.
• Treatments: Everolimus; Sirolimus

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.