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

Infinity Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Everolimus; Drug: IPI-504

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427946

IPI-504-15

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Retaspimycin HCl (IPI-504) and Everolimus

Experimental group

Description:

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.

Treatment:

Drug: IPI-504

Drug: Everolimus