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Study Summary
No. 2005-0155:.......Breast; Solid Tumors......Nuhad K. Ibrahim......Breast Medical Oncology
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Study Summary Title
Study Summary
Number:
2005-0155
Study Title:A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients with Refractory Advanced Solid Tumor Malignancies
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Physician New Patient Referral
Name:Nuhad K. IbrahimPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Breast Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2817
Contact us about clinical trials
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General Information
Disease Group:Breast
Solid Tumors
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Prestudy and days 0, 1, 2, 4, 7, 14, 21, 22, 23, 25, 28, 35, 42, 49, and 56
and then according to standard of care.
Treatment
Agents:
BavituximabHome Care:None
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Outpatient only
Description/
Intervention:
The goal of this clinical research study is to find the highest safe dose of
the new drug bavituximab (3G4 monoclonal antibody) that can be given to
patients with advanced solid tumors, including breast cancer. The general
safety and tolerability of this drug will also be studied.
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Study Objectives / Outcomes
Objectives are
· To determine the safety and tolerability of bavituximab administered intravenously to patients with refractory advanced cancer.
· To characterize the pharmacokinetic profile of bavituximab administered intravenously to patients with refractory advanced cancer.
· To define the dose limiting toxicities (DLT), maximum tolerated dose (MTD) and/or maximum effective dose (MED) of bavituximab administered intravenously to patients with refractory advanced cancer.
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Study Status Information
Study Activation / Registration Date:10/27/2005
IRB Review and Approval Date:05/04/2005
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:30 - 40 patients
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Written informed consent has been obtained.

2) Adults over age 18 years of age with a life expectancy of at least 3 months.

3) Patients must have evaluable, histologically or cytologically confirmed, refractory advanced solid tumor malignancy for which standard curative measures do not exist or are no longer effective

4) ECOG Performance Status </= 1

5) Adequate hematologic function (ANC >/= 1,500 cells/microL; hemoglobin >/= 9 g/dL; platelets >/= 100,000/microL and </= 500,000/microL)

6) Adequate renal function (serum creatinine </= 1.5 mg/dL or calculated creatinine clearance > 60 ml/min)

7) Adequate hepatic function (bilirubin </= 1.5 x ULN, ALT </= 3 x ULN, AST </= 3 x ULN)

8) Normal coagulation profile (PT/INR and aPTT within institutional normal limits)

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

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

11) Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

Exclusion Criteria:1) Prior exposure to any chimeric antibody

2) Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding

3) Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)

4) Any history of thromboembolic events (e.g., DVT or PE) including central venous catheter-related thrombosis within the past 12 months

5) Any evidence or history of hypercoagulable state (e.g., shortened aPTT)

6) Concurrent therapy with oral or parenteral anticoagulants with exception of low dose anticoagulants to maintain patency of indwelling lines or ports

7) Concurrent hormone therapy (e.g., estrogen contraceptives, hormone replacement, anti-estrogen)

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

9) Investigational therapy within 4 weeks of day 0

10) Evidence of CNS metastatic disease at prestudy (normal MRI of the brain required); patients with a known history of CNS metastatic disease that were effectively treated and have a normal MRI at prestudy are eligible

11) Major surgery within 4 weeks of day 0

12) Pregnant or nursing women

13) All patients of reproductive potential must agree to use an approved form of barrier contraception.

14) Uncontrolled intercurrent disease (e.g. diabetes, hypertension, thyroid disease)

15) Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack.

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

17) Any history of any condition requiring treatment (past or current) with coumarin-type agents within past 12 months

18) Cardiac arrhythmia requiring medical therapy.

19) Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).

20) Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (e.g. phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists) or steriods.

21) Known chronic infection with HIV or hepatitis.

22) Washout periods of concurrent medication to be observed: NSAIDs 1 week; Steriods 4 weeks; Aspirin 3 weeks; Anticoagulants (e.g. prophylactic heparin or enoxaparin) 3 weeks; Hormones (estrogenic compounds; anti-estrogens progesterone compounds) 6 weeks

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Links
Registration Number: NCT00129337
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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