Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022542
Status:
TERMINATED
Last Update Posted:
2015-04-15
First Post:
2001-08-10
Brief Title:
BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Epothilone B Analog BMS-247550 in Advanced Soft Tissue Sarcomas
Status:
TERMINATED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced soft tissue sarcoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the confirmed response rate of patients with advanced soft tissue sarcoma treated with BMS-247550
II Determine the overall survival and progression-free survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive 2 additional courses
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 14-29 patients will be accrued for this study within 8 months
I Determine the confirmed response rate of patients with advanced soft tissue sarcoma treated with BMS-247550
II Determine the overall survival and progression-free survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive 2 additional courses
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 14-29 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| N01CM17104 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17104 |
| NCI-2012-02397 | REGISTRY | None | None |
| MAYO-MC007C | None | None | None |
| CDR0000068829 | None | None | None |
| NCI-3852 | None | None | None |
| MC007C | OTHER | None | None |
| 3852 | OTHER | None | None |