Viewing Study NCT00129337



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Study NCT ID: NCT00129337
Status: COMPLETED
Last Update Posted: 2011-03-01
First Post: 2005-08-10

Brief Title: Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies
Sponsor: Peregrine Pharmaceuticals
Organization: Peregrine Pharmaceuticals

Study Overview

Official Title: A Multicenter Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody Bavituximab in Patients With Refractory Advanced Solid Tumor Malignancies
Status: COMPLETED
Status Verified Date: 2011-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: True
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 humanmurine monoclonal antibody directed against aminophospholipids Bavituximab is Peregrines 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 01 mg bavituximab per kilogram body weight 01 mgkg Successive patient cohorts will receive 03 10 and 30 mgkg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None