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

Breast Cancer Clinical Trial

Official title:

A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669591
• Other study ID #: PPHM 0704
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2008
• Last updated: April 19, 2017
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Georgia	Ltd. Oncological Center	Batumi
Georgia	JSC. National Cancer Centre	Lisi Lake	Tbilisi
Georgia	Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str	Tbilisi
Georgia	Ltd. Tbilisi Oncological Dispensary	Tblisi

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer		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.
Secondary	Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.		Approximately 1 year