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 of tivantinib administered orally twice daily to children with refractory solid tumors. II. To define and describe the toxicities of tivantinib administered on this schedule. III. To characterize the pharmacokinetics of tivantinib (capsule as well as powder formulation) in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of tivantinib within the confines of a phase 1 study. II. To preliminarily investigate whether cytochrome P450 (CYP450) polymorphisms impact pharmacokinetics or toxicity of tivantinib. III. To preliminarily investigate whether tumor c-Met and/or hepatocyte growth factor (HGF) expression or downstream c-Met signaling correlate with clinical response to tivantinib. OUTLINE: This is a dose-escalation study. Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
