Trials / Completed
CompletedNCT00064220
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | soblidotin |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2005-12-01
- Completion
- 2005-12-01
- First posted
- 2003-07-09
- Last updated
- 2012-05-16
Locations
6 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00064220. Inclusion in this directory is not an endorsement.