Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

March 23, 2011 updated by: Peregrine Pharmaceuticals

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

This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic 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

  • India
      • Bangalore, India
        • Rajalakshmi Multispecialty Hospital
      • Banglore, India
        • Bangalore Institute of Oncology
      • Chennai, India
        • Apollo Specialty Hospitals
      • Hyderabaad, India
        • Nizam's Institute of Medical Sciences
      • Kerala, India
        • Regional Cancer Center
      • Kolkata, India
        • Medical College Hospital
      • Mysore, India
        • Bharath Hospital and Institite of Oncology
      • Nashik, India
        • Curie Manavata Cancer Center
      • Pune, India
        • Ruby Hall Clinic

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:

  • Living in India for the duration of the study
  • Adult females over age 18 years of age with a life expectancy of at least 3 months
  • Confirmed breast cancer with evidence of locally advanced or metastatic disease
  • Disease that is measurable by radiology imaging
  • Ambulatory and capable of all selfcare but unable to carry out any work activities.
  • Adequate laboratory results (hematologic, renal, hepatic)
  • Negative pregnancy test

Exclusion Criteria:

  • History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
  • Any history of thromboembolic events (clots within blood vessels)
  • Ongoing treatment with high doses of anticoagulants
  • Use of hormone therapy
  • Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
  • Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
  • Radiotherapy within 2 weeks entering the study
  • Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
  • Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
  • Diagnosed and active CNS disease or metastatic lesions
  • Major surgery within 4 weeks of starting the study
  • Pregnant or nursing
  • Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
  • History of heart disease
  • History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
  • Diagnosed with HIV or hepatitis

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to determine the overall response rate (CR+PR)
Time Frame: Until disease progression
Until disease progression

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

July 1, 2008

Primary Completion (Actual)

July 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 (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 0702

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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