A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin
- Registration Number
- NCT00420186
- Lead Sponsor
- Bristol-Myers Squibb
- 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 on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- 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 Criteria
- 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®
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 BMS-690514 -
- Primary Outcome Measures
Name Time Method To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation upon occurrence
- Secondary Outcome Measures
Name Time Method Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research upon occurence Describe anti-tumor activity upon occurence
Trial Locations
- Locations (3)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Local Institution
🇬🇧Manchester, Greater Manchester, United Kingdom