ADVL1111: A Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197, IND# 112603) in Children With Relapsed or Refractory Solid Tumors

What is the purpose of this study?

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.

Who can participate?

Patients between the ages of 13 months to 21 years with relapsed or refractory solid tumors are eligible for this study. Download or print the PDF below for further inclusion criteria.

Ages

  • 13  months old and above
  • Under 21  years old

Conditions

  • Cancer - Brain and Spinal Tumors
  • Cancer - Kidney Tumors
  • Cancer - Liver Tumors
  • Cancer - Musculoskeletal Tumors
  • Cancer - Neuroblastoma
  • Cancer - Neurofibromatosis Tumors
  • Cancer - Retinoblastoma

What is involved?

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.

Who should I contact for more information?

For more information contact:

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799

Where can I find additional information?