12
Participants
Start Date
June 30, 2008
Primary Completion Date
September 30, 2009
Study Completion Date
September 30, 2009
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Local Institution, Chuo-Ku
Lead Sponsor
R-Pharm
INDUSTRY