Hirogen, regarding Bavi side effects, they are cited in this abstract of a 2011 Bavi dose escalation study published in CCR, FYI. The study was less than two months so therapeutic effects were incidental.
KT
Phase I Safety and Pharmacokinetic Study of Bavituximab, a Chimeric Phosphatidylserine-Targeting Monoclonal Antibody, in Patients with Advanced Solid Tumors
David E. Gerber1, Alison T. Stopeck2, Lucas Wong3, Lee S. Rosen4, Philip E. Thorpe1, Joseph S. Shan5, and Nuhad K. Ibrahim6
+ Author Affiliations
Authors' Affiliations: 1Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; 2Arizona Cancer Center, University of Arizona, Tucson, Arizona; 3Scott & White Hospital, Temple, Texas; 4Premiere Oncology, Santa Monica, California; 5Peregrine Pharmaceuticals, Inc., Tustin, California; and 6The University of Texas MD Anderson Cancer Center, Houston, Texas
Corresponding Author:
Nuhad K. Ibrahim, Breast Medical Oncology Department, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030. Phone: 713-792-2817; Fax: 713-794-4385; E-mail: nibrahim@mdanderson.org
Abstract
Purpose: Bavituximab is a chimeric immunoglobulin G1 phosphatidylserine-targeting monoclonal antibody that triggers vascular disruption and enhances antitumor immune response. This phase I study assessed the safety and pharmacokinetics of bavituximab in patients with advanced solid tumors.
Experimental Design: Patients with refractory advanced solid tumors were enrolled into four sequential dose-escalation cohorts (0.1, 0.3, 1, or 3 mg/kg bavituximab weekly) with two dosing schedules. Patients in the 0.1 and 0.3 mg/kg cohorts received bavituximab on days 0, 28, 35, and 42. Patients in the 1 and 3 mg/kg cohorts were administered bavituximab on days 0, 7, 14, and 21. Safety, pharmacokinetics, and tumor response were assessed.
Results: Twenty-six patients were accrued. No maximum tolerated dose was reached. Six serious adverse events occurred in five patients, including one pulmonary embolism at 3 mg/kg, which was the only dose-limiting toxicity (DLT) in the study. Bavituximab half-life ranged from 37 to 47 hours, with no accumulation seen following administration of multiple doses. Activated partial thromboplastin time was modestly prolonged in vitro at the highest dose tested. As assessed on day 56, a total of 18 patients were evaluable for efficacy, of whom 10 had disease progression and none had an objective response.
Conclusions: Bavituximab was well tolerated at doses ranging up to 3 mg/kg weekly. Pharmacokinetic studies support a weekly dosing regimen. Additional phase I and II clinical trials are in progress to investigate bavituximab in combination with chemotherapy and other molecularly targeted agents. Clin Cancer Res; 17(21); 1–9. ©2011 AACR.
Footnotes
Note: This article was presented, in part, at the 101st Annual Meeting of the American Association for Cancer Research, April 17–21, 2010, in Washington, DC.
Received April 22, 2011.
Revision received July 23, 2011.
Accepted July 25, 2011.
©2011 American Association for Cancer Research.
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