Childhood Solid Neoplasm Clinical Trial
Official title:
A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197) in Children With Relapsed or Refractory Solid Tumors
This phase I trial studies the side effects and best dose of tivantinib in treating younger patients with solid tumors that have returned after a period of improvement or have not responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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