Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab

Criteria

Inclusion Criteria:

• At least 18 years of age with life expectancy of 3 months

• Evaluable, histologically or cytologically confirmed, refractory advanced solid tumor malignancy

• ECOG score of less than or equal to 1

• Adequate hematologic function (absolute neutrophil count [ANC] greater than or equal to 1,500 cells/uL; hemoglobin greater than or equal to 9 g/dL; platelets greater than or equal to 100,000/uL and less than or equal to 500,000/uL)

• Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)

• Adequate hepatic function (bilirubin less than or equal to 1.5 x ULN; ALT less than or equal to 3 x ULN; AST less than or equal to 3 x ULN)

• Normal coagulation profile (prothrombin time/international normalized ratio [PT/INR] and activated partial thromboplastin time [aPTT] within institutional normal limits)

• D-dimer less than or equal to 2 times upper limit of institutional normal

• New York Heart Association classification I or II for patients with significant cardiopulmonary disease

• Female patients must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception

Exclusion Criteria:

• Prior exposure to any chimeric antibody

• Any evidence of clinically significant bleeding

• Known history of bleeding diathesis or coagulopathy

• Any history of thromboembolic events including central venous catheter-related thrombosis within the past 12 months

• Any evidence or history of hypercoagulable state (eg, shortened aPTT)

• Concurrent therapy with oral or parenteral anticoagulants

• Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen)

• Chemotherapy, immunotherapy or radiotherapy within 4 weeks of day 0 (6 weeks for nitrosoureas and mitomycin C) or have not recovered from treatment-related side effects due to agents administered more than 4 weeks earlier (stable, non-hematological residual toxicities of Grade 1 or less and Grade 2 dry skin or alopecia are allowed)

• Investigational therapy within 4 weeks of day 0

• Evidence of central nervous system (CNS) metastatic disease at prestudy (no active brain metastases on magnetic resonance imaging [MRI] at prestudy)

• Major surgery within 4 weeks of day 0

• Pregnant or nursing women

• Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)

• Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack

• A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin

• A history of any condition requiring treatment (past or current) with coumarin-type agents within the past 12 months

• Cardiac arrhythmia requiring medical therapy

• Serious non-healing wound

• Requirement for chronic daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs), anti-platelet drugs (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists) or steroids

• Known chronic infection with HIV or hepatitis