Clinical trial NCT01427946: Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
Official title: A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: KRAS mutant
Non-Small Cell Lung Cancer
NSCLC
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to three years from last patient study visit
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Up to three years from last patient study visit
measure: Time to Progression
timeFrame: Up to three years from last patient study visit
measure: Overall Survival
timeFrame: Up to three years from last patient study visit
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Infinity Pharmaceuticals, Inc.
name: Tess Schmalbach, MD, PhD
role: STUDY_DIRECTOR
References: