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Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery

Phase II Study of the Angiopoietin-1 and -2 Peptibody AMG 386 for the Treatment of Angiosarcoma

NCT01623869•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial studies how well trebananib works in treating patients with advanced angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR), defined as complete response (CR) +partial response (PR), in patients with advanced, unresectable angiosarcoma treated with trebananib (AMG 386). SECONDARY OBJECTIVES: I. To evaluate the progression-free survival (PFS) and overall survival (OS) of patients with advanced, unresectable angiosarcoma treated with AMG 386. TERTIARY OBJECTIVES: I. To correlate ORR, PFS, and OS with: Baseline and post-treatment changes in expression of angiopoietin 2 (Ang2) and TEK tyrosine kinase, endothelial (Tie2) by immunohistochemistry (IHC); Serum levels of angiopoietin 1 (Ang1) and Ang2; Baseline and post-treatment changes in phospho-receptor tyrosine kinase status of TIE2, vascular endothelial growth factor receptor 2 (VEGFR-2), phosphatidylinositol 3 kinase (PI3K), mitogen-activated protein kinase Inhibitor (MEK) in tumor tissue; Mutational status of VEGFR-2 and amplification of v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)/fms-related tyrosine kinase 4 (FLT4). OUTLINE: Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks and then every 6 months for 18 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically confirmed angiosarcoma that is unresectable
•Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
•Patients must have had =\< 4 prior systemic treatment regimens
•Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky \>= 70%
•Life expectancy of greater than 3 months
•Leukocytes \>= 3,000/mcL
•Absolute neutrophil count \>= 1,500/mcL
•Hemoglobin \>= 8.5g/dL
•Platelet count \>= 60,000/mcL
•Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
+12 more criteria

Exclusion Criteria

•No known history of brain metastases
•History of clinically significant bleeding within 6 months of enrollment/randomization
•No unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 \>= grade 2 in severity except alopecia
•Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
•Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater (CTCAE version 4.0) peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
•Major surgery within 28 days prior to enrollment or still recovering from prior surgery
•Treatment within 30 days prior to enrollment with strong immune modulators including, but not limited to, systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide, and targeted immune modulators such as abatacept (CTLA-4- -Ig),adalimumab, alefacept, anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab
•Non-healing wound
•Subject not consenting to the use of highly effective contraceptive precautions (e.g., double barrier method \[i.e., condom plus diaphragm\]) during the course of the study and for 6 months after administration of the last study medication
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to AMG 386
+6 more criteria

Locations (70)

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Oncare Hawaii Inc-POB II