Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Lung Cancer
- Registration Number
- NCT00431015
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
- Measurable disease by RECIST 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria Every 6 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mary Crowley Cancer Research Centers - Baylor
🇺🇸Dallas, Texas, United States
Mary Crowley Cancer Research Centers - Medical City
🇺🇸Dallas, Texas, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States