Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
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
1 other identifier
interventional
88
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lung-cancer
Started Jan 2007
Typical duration for phase_1 lung-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 10, 2012
December 1, 2012
4.6 years
January 31, 2007
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
Every 6 weeks
Interventions
IV Hsp90 inhibitor
Eligibility Criteria
You may qualify if:
- Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
- Measurable disease by RECIST criteria.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06519, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Mary Crowley Cancer Research Centers - Medical City
Dallas, Texas, 75201, United States
Mary Crowley Cancer Research Centers - Baylor
Dallas, Texas, 75246, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lecia Sequist, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 2, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2011
Study Completion
December 1, 2011
Last Updated
December 10, 2012
Record last verified: 2012-12