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

April 19, 2017 updated by: Peregrine Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Batumi, Georgia, 6000
        • Ltd. Oncological Center
      • Tbilisi, Georgia, 0176
        • Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str
      • Tblisi, Georgia, 0171
        • Ltd. Tbilisi Oncological Dispensary
    • Tbilisi
      • Lisi Lake, Tbilisi, Georgia, 0177
        • JSC. National Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.
Time Frame: Approximately 1 year
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 0704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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