Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003165
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Doxorubicin in Treating Women With Advanced Breast Cancer
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of PK1 in Women With Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Giving drugs in different forms may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of doxorubicin-HPMA conjugate PK1 in women with advanced breast cancer
OUTLINE This is an open label multicenter study Patients receive doxorubicin-HPMA conjugate PK1 by intravenous infusion once every 3 weeks Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease
PROJECTED ACCRUAL 14-25 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients receive doxorubicin-HPMA conjugate PK1 by intravenous infusion once every 3 weeks Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease
PROJECTED ACCRUAL 14-25 patients will be accrued for this study
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 |
|---|---|---|---|
| CRC-PHASE-II-PH2038 | None | None | None |
| EU-97028 | None | None | None |