NCT01725191

Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors

A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197) in Children With Relapsed or Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 13 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Childhood Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Tivantinib	Given PO

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-11-12
• Last updated: 2015-07-02

Locations

20 sites across 2 countries: United States, Canada