Status:
COMPLETED
Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lo...
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 dire...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00129337
Start Date
June 1 2005
End Date
August 1 2009
Last Update
March 1 2011
Active Locations (6)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Premiere Oncology
Santa Monica, California, United States, 90404
3
The West Clinic
Memphis, Tennessee, United States, 38120
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390