A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669591
First received: April 28, 2008
Last updated: August 26, 2010
Last verified: August 2010

April 28, 2008
August 26, 2010
January 2008
June 2010   (final data collection date for primary outcome measure)
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer [ Time Frame: Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00669591 on ClinicalTrials.gov Archive Site
Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer

The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Bavituximab
Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.
Experimental: 1
Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression
Intervention: Drug: Bavituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
August 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult females over age 18 with life expectancy of at least 3 months
  • Histologically or cytologically confirmed locally advanced or metastatic breast cancer
  • One and only one prior chemotherapy regimen (no prior docetaxel)
  • Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
  • Adequate hematologic, renal, and hepatic function;

Exclusion Criteria:

  • Known history of bleeding diathesis or coagulopathy
  • Any current evidence of clinically significant bleeding
  • Any history of thromboembolic events
  • Concurrent hormone therapy
  • Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Georgia
 
NCT00669591
PPHM 0704
No
A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine
Peregrine Pharmaceuticals
Not Provided
Not Provided
Peregrine Pharmaceuticals
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP