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

Peregrine Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Carcinoma Breast Stage IV

Treatments

Drug: Bavituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00669565

PPHM 0702

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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