Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064220
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2003-07-08
Brief Title:
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-03061 | None | None | None |
| DAIICHI-1027A-PRT007 | None | None | None |
| CPMC-IRB-20030512 | None | None | None |