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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01427946
First received: August 31, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: IPI-504
Drug: Everolimus
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.

  • Time to Progression [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    Time to progression (TTP), defined as time from study entry to progression.

  • Overall Survival [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: IPI-504
Other Name: retaspimycin hydrochloride
Drug: Everolimus
Other Name: Afinitor

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427946

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Pedro Santabarbara, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01427946     History of Changes
Other Study ID Numbers: IPI-504-15
Study First Received: August 31, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
KRAS mutant
Non-Small Cell Lung Cancer
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 19, 2014