- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00129337
Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies
February 28, 2011 updated by: Peregrine Pharmaceuticals
A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies
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.
Study Overview
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 (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.
Study Type
Interventional
Enrollment (Anticipated)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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California
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Santa Monica, California, United States, 90404
- Premiere Oncology
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Tennessee
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Memphis, Tennessee, United States, 38120
- The West Clinic
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Temple, Texas, United States, 76508
- Scott & White Hospital, Center for Cancer Prevention and Care
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
0.1 mg/kg
|
Bavituximab is a sterile drug solution supplied in glass bottles.
Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
|
EXPERIMENTAL: 2
0.3 mg/kg
|
Bavituximab is a sterile drug solution supplied in glass bottles.
Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
|
EXPERIMENTAL: 3
1 mg/kg
|
Bavituximab is a sterile drug solution supplied in glass bottles.
Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
|
EXPERIMENTAL: 4
3 mg/kg
|
Bavituximab is a sterile drug solution supplied in glass bottles.
Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adverse events
Time Frame: Study Completion
|
Study Completion
|
laboratory evaluations
Time Frame: Study Completion
|
Study Completion
|
human anti-chimeric antibody
Time Frame: Study Completion
|
Study Completion
|
pharmacokinetic analysis
Time Frame: Study Completion
|
Study Completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Study Completion
|
Study Completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nuhad Ibrahim, MD, The University of Texas Md Anderson Cancer Center
- Principal Investigator: Lee Rosen, MD, Premiere Oncology, A Medical Corporation (Santa Monica)
- Principal Investigator: Lucas Wong, MD, Scott & White Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
August 10, 2005
First Submitted That Met QC Criteria
August 10, 2005
First Posted (ESTIMATE)
August 11, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
March 1, 2011
Last Update Submitted That Met QC Criteria
February 28, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPHM 0401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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