Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies

NCT00129337 | Completed Phase 1

• 1 other identifier: PPHM 0401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

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.

Conditions

Tumors

Keywords

monoclonal antibody; phase 1; solid tumor; anti-angiogenesis; refractory advanced solid tumor malignancy

Outcome Measures

Primary Outcomes (4)

• adverse events

  Study Completion

• laboratory evaluations

  Study Completion

• human anti-chimeric antibody

  Study Completion

• pharmacokinetic analysis

  Study Completion

Secondary Outcomes (1)

• tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST)

  Study Completion

Study Arms (4)

1

EXPERIMENTAL

0.1 mg/kg

Drug: Bavituximab

2

EXPERIMENTAL

0.3 mg/kg

Drug: Bavituximab

3

EXPERIMENTAL

1 mg/kg

Drug: Bavituximab

4

EXPERIMENTAL

3 mg/kg

Drug: Bavituximab

Interventions

Bavituximab DRUG

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).

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (6)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Scott & White Hospital, Center for Cancer Prevention and Care

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

bavituximab

Study Officials

• Nuhad Ibrahim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Linda Garland, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Lee Rosen, MD

  Premiere Oncology, A Medical Corporation (Santa Monica)

  PRINCIPAL INVESTIGATOR

• Lucas Wong, MD

  Scott & White Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Lee S Schwartzberg, MD, FACP

  The West Clinic

  PRINCIPAL INVESTIGATOR

• David E Gerber, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 11, 2005
• Study Start: June 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

US (6)