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

This study has been completed.

Sponsor:

Information provided by:

Peregrine Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00669565

First received: April 28, 2008

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 28, 2008
Last Updated Date	March 23, 2011
Start Date ^ICMJE	July 2008
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 29, 2008)	The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00669565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
Official Title ^ICMJE	A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Carcinoma Breast Stage IV
Intervention ^ICMJE	Drug: Bavituximab Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	46
Completion Date	August 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT00669565
Other Study ID Numbers ^ICMJE	PPHM 0702
Has Data Monitoring Committee	No
Responsible Party	A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals Inc.
Study Sponsor ^ICMJE	Peregrine Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Peregrine Pharmaceuticals
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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