Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-30 @ 7:03 PM
Study NCT ID:
NCT01288261
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2011-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
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 paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bavituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with bavituximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
SECONDARY OBJECTIVES:
I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
OUTLINE:
Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
SECONDARY OBJECTIVES:
I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
OUTLINE:
Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-00026 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |