A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies
Sponsor study identifier
interventional
28
1 country
6
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)The purpose of this study is to determine the safety of bavituximab when administered via a vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the body and how long it stays there. The effect of bavituximab on tumor responses will also be examined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 10, 2005
Actual (reported)August 11, 2005
Actual (reported)August 2009
Actual (reported)August 2009
Actual (reported)adverse events
Study Completion
laboratory evaluations
Study Completion
human anti-chimeric antibody
Study Completion
pharmacokinetic analysis
Study Completion
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST)
Study Completion
0.1 mg/kg
0.3 mg/kg
1 mg/kg
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Premiere Oncology
Santa Monica, California, 90404, United States
The West Clinic
Memphis, Tennessee, 38120, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Scott & White Hospital, Center for Cancer Prevention and Care
Temple, Texas, 76508, United States
Nuhad Ibrahim, MD
M.D. Anderson Cancer Center
Linda Garland, MD
University of Arizona
Lee Rosen, MD
Premiere Oncology, A Medical Corporation (Santa Monica)
Lucas Wong, MD
Scott & White Memorial Hospital
First Submitted
August 10, 2005
First Posted
August 11, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
3 mg/kg
Contact the study team to confirm eligibility.
Lee S Schwartzberg, MD, FACP
The West Clinic
David E Gerber, MD
University of Texas Southwestern Medical Center
Study Completion
August 2009
Actual (reported)Last Updated
March 1, 2011
Record last verified: 2011-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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