Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Infinity Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00431015
First received: January 31, 2007
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the anti-tumor activity of IPI-504.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: IPI-504 |
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 I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients |
Resource links provided by NLM:
Further study details as provided by Infinity Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 88 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: IPI-504
IV Hsp90 inhibitor
IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
- Measurable disease by RECIST criteria.
Exclusion Criteria:
- Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy.
- Inadequate hematologic or renal or hepatic function
- Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431015
Locations
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
| Mount Sinai Comprehensive Cancer Center | |
| Miami, Florida, United States, 33140 | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Texas | |
| Mary Crowley Cancer Research Centers - Baylor | |
| Dallas, Texas, United States, 75246 | |
| Mary Crowley Cancer Research Centers - Medical City | |
| Dallas, Texas, United States, 75201 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Lecia Sequist, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00431015 History of Changes |
| Other Study ID Numbers: | IPI-504-03 |
| Study First Received: | January 31, 2007 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Infinity Pharmaceuticals, Inc.:
|
Lung Cancer Cancer of the lung Non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Pericardial Effusion Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013