Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00064220|
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : May 16, 2012
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: soblidotin||Phase 2|
- 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 this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064220
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Veterans Affairs Medical Center - San Juan|
|San Juan, Puerto Rico, 00927-5800|
|Study Chair:||Juan Pagan||Daiichi Sankyo, Inc.|