BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00004927
- Lead Sponsor
- R-Pharm
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug in this patient population. III. Determine any preliminary evidence of antitumor activity of this drug in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States