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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

April 28, 2008
March 23, 2011
July 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00669565 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma Breast Stage IV
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
August 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00669565
PPHM 0702
No
A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals Inc.
Peregrine Pharmaceuticals
Not Provided
Not Provided
Peregrine Pharmaceuticals
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP