Status:
COMPLETED
Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Carcinoma Breast Stage IV
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00669565
Start Date
July 1 2008
End Date
August 1 2010
Last Update
March 24 2011
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
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