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

Sponsor

Peregrine Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00669565

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Breast Stage IV	Drug: Bavituximab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Outcome Measures

Primary Outcome Measures

The primary objective of this study is to determine the overall response rate (CR+PR) [Until disease progression]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Rajalakshmi Multispecialty Hospital	Bangalore	India
2	Bangalore Institute of Oncology	Banglore	India
3	Apollo Specialty Hospitals	Chennai	India
4	Nizam's Institute of Medical Sciences	Hyderabaad	India
5	Regional Cancer Center	Kerala	India
6	Medical College Hospital	Kolkata	India
7	Bharath Hospital and Institite of Oncology	Mysore	India
8	Curie Manavata Cancer Center	Nashik	India
9	Ruby Hall Clinic	Pune	India

Sponsors and Collaborators

Peregrine Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00669565

Other Study ID Numbers:

PPHM 0702

First Posted:

Apr 30, 2008

Last Update Posted:

Mar 24, 2011

Last Verified:

Mar 1, 2011

Keywords provided by , ,

Locally Advanced or Metastatic Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms

Bavituximab

Study Results

No Results Posted as of Mar 24, 2011