Status:
COMPLETED
A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer (Solid Tumors)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered ...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
- Centrally located squamous cell carcinoma of the lung is permitted
- ECOG performance status of 0-1
- Life expectancy of at least 3 months
- Men and women age 18 and above
Exclusion
- Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
- Peripheral neuropathy ≥Grade 1 for any reason
- History of thromboembolic disease or bleeding diatheses within the last 6 months
- Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
- Serious, uncontrolled medical disorder or active infection
- Uncontrolled or significant cardiac disease
- Uncontrolled hypertension (150/100)
- Allergy to Cremophor EL®
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00420186
Start Date
October 1 2007
End Date
February 1 2012
Last Update
September 30 2016
Active Locations (4)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
3
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
4
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX