Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT01288261
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
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.
Study:
NCT01288261
Study Brief:
Protocol Section:
NCT01288261