Status:
COMPLETED
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer
Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.
Eligibility Criteria
Inclusion
- Men and women 18 and older
- Diagnosis of any solid tumor
- ECOG performance status score 0-1
- Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
- Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)
Exclusion
- Treatment with other TKIs within the past 4 weeks
- Patients with brain metastasis
- Patients with centrally located squamous cell carcinoma of the lung
- Major gastrointestinal surgery which may affect absorption of the drug
- Any surgery within last 4 weeks
- History of thromboembolism
- Severe unmanageable diarrhea
- Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
- Part B/Cohort I erlotinib-naive subjects
- Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00329004
Start Date
August 1 2006
End Date
July 1 2009
Last Update
January 25 2011
Active Locations (7)
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1
Indiana University Med Center
Indianapolis, Indiana, United States, 46202
2
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
3
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
4
Local Institution
Toronto, Ontario, Canada, M5G 2M9