Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
- Registration Number
- NCT01018966
- Lead Sponsor
- R-Pharm
- Brief Summary
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- 20 years or older
- Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors
Exclusion Criteria
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ixabepilone Ixabepilone -
- Primary Outcome Measures
Name Time Method To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) 3-week treatment cycles until unacceptable toxicity
- Secondary Outcome Measures
Name Time Method To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria 3-week treatment cycles To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot Cycle 1 (first 3 weeks of study therapy) To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 3-week treatment cycles until unacceptable toxicity