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

NCT00669591 | Completed Phase 2

• 1 other identifier: PPHM 0704
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Breast Cancer

Keywords

breast cancer; docetaxel chemotherapy; bavituximab; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.

  Approximately 1 year

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Bavituximab

Interventions

Bavituximab DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (4)

JSC. National Cancer Centre

Lisi Lake, K'alak'i T'bilisi, 0177, Georgia

Location

Ltd. Oncological Center

Batumi, 6000, Georgia

Location

Ltd. Tbilisi Oncological Dispensary

Tbilisi, 0171, Georgia

Location

Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str

Tbilisi, 0176, Georgia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

GE (4)