A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197, IND# 112603) in Children With Relapsed or Refractory Solid Tumors

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
13 months to 21 years, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01725191
Protocol IDs
NCI-2012-02163 (primary)
U01CA097452
ADVL1111
Study Sponsor
National Cancer Institute

Summary

This phase I trial studies the side effects and best dose of tivantinib in treating younger patients with relapsed or refractory solid tumors. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Objectives

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.

Treatment Sites in Georgia


Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org