Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To estimate the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of trebananib (AMG 386) administered as a weekly intravenous infusion to children with recurrent or refractory solid tumors. II. To determine the tolerability of the solid tumor MTD and/or RP2D of AMG 386 in children with central nervous system (CNS) tumors. III. To define and describe the toxicities of AMG 386 administered on this schedule. IV. To characterize the pharmacokinetics and immunogenicity of AMG 386 in children with refractory cancer. V. To measure changes in vascular permeability relative to baseline, evaluated by magnetic resonance imaging (MRI) perfusion, following AMG 386 administration in pediatric patients with CNS tumors. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of AMG 386 within the confines of a Phase 1 study. II. To measure biologic markers of angiogenesis with potential for correlation with disease response. OUTLINE: This is a dose-escalation study (part 1) followed by a safety and imaging study (part 2). Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 to 6 months for up to 1 year.
Age
2–21
Sex
ALL
Healthy volunteers
Not accepted
