A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
January 24, 2011 updated by: Bristol-Myers Squibb
Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors
The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shizuoka
-
Sunto-Gun, Shizuoka, Japan, 411-8777
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have measurable disease
- Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
- ECOG PS: 0-1
Exclusion Criteria:
- Subjects with centrally located squamous cell carcinoma of the lung
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 1
4 dosages
|
Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dose Limiting Toxicity
Time Frame: at the end of the first cycle of the study
|
at the end of the first cycle of the study
|
|
Maximum Tolerated Dose
Time Frame: at the end of the first cycle of the study
|
at the end of the first cycle of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess any preliminary evidence of anti-tumor activity observed with BMS-582664
Time Frame: at the end of the study
|
at the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol Myers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
October 20, 2006
First Submitted That Met QC Criteria
October 20, 2006
First Posted (Estimate)
October 23, 2006
Study Record Updates
Last Update Posted (Estimate)
January 25, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA182-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.