A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies
The genetic variations observed in most advanced cancers decrease the effectiveness of many
anti-cancer agents through the development of drug resistance. Therefore, alternative
approaches to the direct targeting of cancer cells are urgently needed. Bavituximab is the
generic name for a chimeric (human/murine) monoclonal antibody directed against
aminophospholipids. Bavituximab is Peregrine's first investigational product under its
anti-phospholipid therapy technology platform. Anti-phospholipid therapy is a novel approach
to treating cancer. It is based on the finding that aminophospholipids, which are basic
components of the inner surface of cells become externally exposed in response to certain
disease states such as cancer. Laboratory and animal studies have demonstrated that
bavituximab specifically targets cancer cells and inhibits tumor growth in a variety of
experimental cancer models. This study will examine the safety and tolerability of
bavituximab when administered to patients with advanced solid tumor cancers that are
unresponsive to current therapies. Cohorts of 6 patients each will be treated at the
starting dose of 0.1 mg bavituximab per kilogram body weight (0.1 mg/kg). Successive patient
cohorts will receive 0.3, 1.0 and 3.0 mg/kg of bavituximab. Patients will be followed for a
total of 56 days. Patients who demonstrate an objective tumor response will be offered
further bavituximab treatment on an extension protocol.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
adverse events
Study Completion
Yes
Nuhad Ibrahim, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
United States: Food and Drug Administration
PPHM 0401
NCT00129337
June 2005
August 2009
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Texas Southwestern Medical Center | Dallas, Texas |
The West Clinic | Memphis, Tennessee 38120 |
Premiere Oncology | Santa Monica, California 90404 |
Scott & White Hospital, Center for Cancer Prevention and Care | Temple, Texas 76508 |