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

November 12, 2014 updated by: Infinity Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retaspimycin HCl (IPI-504) and Everolimus
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.
Drug: Everolimus
Other Names:
  • Afinitor
Drug: IPI-504
Other Names:
  • retaspimycin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to three years from last patient study visit
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Up to three years from last patient study visit
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
Time to Progression
Time Frame: Up to three years from last patient study visit
Time to progression (TTP), defined as time from study entry to progression.
Up to three years from last patient study visit
Overall Survival
Time Frame: Up to three years from last patient study visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Investigators

  • Study Director: Tess Schmalbach, MD, PhD, Infinity Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-504-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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