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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427946
• Other study ID #: IPI-504-15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 31, 2011
• Last updated: November 12, 2014
• Start date: July 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• IPI-504

• Everolimus

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	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).	Up to three years from last patient study visit	No
Secondary	Progression Free Survival	Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.	Up to three years from last patient study visit	No
Secondary	Time to Progression	Time to progression (TTP), defined as time from study entry to progression.	Up to three years from last patient study visit	No
Secondary	Overall Survival	Overall survival (OS), defined as time from study entry to death due to any cause, in patients with KRAS mutant NSCLC administered IPI-504 plus everolimus.	Up to three years from last patient study visit	No