Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020904
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-07-11
Brief Title:
BMS-247550 in Treating Women With Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the clinical activity of BMS-247550 in terms of tumor response rate in women with taxane-resistant metastatic breast cancer
Determine the safety of this drug in these patients
Determine the duration of response time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 4 additional courses beyond CR Responding patients may receive additional courses at the investigators discretion
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-50 patients will be accrued for this study within 12 months
Determine the clinical activity of BMS-247550 in terms of tumor response rate in women with taxane-resistant metastatic breast cancer
Determine the safety of this drug in these patients
Determine the duration of response time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 4 additional courses beyond CR Responding patients may receive additional courses at the investigators discretion
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-50 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 |
|---|---|---|---|
| NCI-G01-1967 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068729 | REGISTRY | None | None |
| BMS-CA163-009 | None | None | None |
| CPMC-IRB-13916 | None | None | None |