A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy
- Determine the objective tumor response rate in patients with advanced or metastatic
soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when
treated with soblidotin.
- Determine the duration of response in patients treated with this drug.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time and 12-month survival rate of patients treated with
- Determine the quantitative and qualitative toxic effects of this drug in these
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.
Masking: Open Label, Primary Purpose: Treatment
Daiichi Sankyo Inc.
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|