Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer
This study is currently recruiting participants.
Verified December 2012 by Infinity Pharmaceuticals, Inc.
Sponsor:
Infinity Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01427946
First received: August 31, 2011
Last updated: December 4, 2012
Last verified: December 2012
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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: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (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:
- ≥18 years of age
- Voluntarily sign an informed consent form (ICF).
- Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV
- Archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
- Experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
- ECOG performance of 0-1.
Exclusion Criteria:
- Prior treatment with IPI-504 or other Hsp90 inhibitors.
- Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus), rapamycin, or other mTOR inhibitors.
- Has not recovered from any toxicities related to prior treatment (to Grade 1 or baseline), excluding alopecia.
- Inadequate hematologic function defined as:
- Inadequate hepatic function defined by:
- Inadequate renal function defined by serum creatinine >1.5 x ULN.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427946
Contacts
| Contact: Travis Quigley | 617-453-1000 | |
| Contact: Patricia Pimentel | 617-453-1000 |
Locations
| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Sarah Rippke 720-848-0685 Sarah.Rippke@ucdenver.edu | |
| Principal Investigator: David Ross Camidge, MD | |
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Sara Collins, RN, BSN 813-745-4616 sara.collins@moffitt.org | |
| Principal Investigator: Jhanelle Gray, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Peter Laub 617-582-8013 plaub@partners.org | |
| Principal Investigator: Pasi Janne, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Peter Laub 617-582-8013 plaub@partners.org | |
| Principal Investigator: Pasi Janne, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10017 | |
| Contact: Bafemi Silver 646-888-4359 silverb@mskcc.org | |
| Principal Investigator: Greg Riley, MD | |
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: | December 4, 2012 |
| 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Everolimus |
Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013