Solid Tumors
Conditions
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.
Interventions
DRUGIxabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Sponsors
R-Pharm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed