A Phase I Study Of The C-Met Inhibitor Tivantinib (ARQ 197, IND#112603) In Children With Relapsed or Refractory Solid Tumors (ADVL1111)

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Research

Protocol

ADV1111: A Phase I Study Of The C-Met Inhibitor Tivantinib (ARQ 197, IND#112603) In Children With Relapsed or Refractory Solid Tumors (ADVL1111)

Diseases

Solid Tumor : Relapsed or refractory solid tumors or brain tumors

Description

This is a phase I study of a drug called tivantinib. Tivantinib is considered experimental because it has not been approved by the Food and Drug Administration (FDA) for use in children.

Participants will receive oral tivantinib twice daily. Participants in Part A will receive tivantinib capsules, and participants in Part B will receive tivantinib powder sprinkled on food. In addition, we will check blood levels of this drug and define side effects.

Objectives

To find the highest safe dose of tivantinib that can be given without causing severe side effects.
To learn what kind of side effects tivantinib can cause.
To learn more about the pharmacology (how your body handles the drug) of tivantinib.
To learn more about the biology of tivantinib.
To determine whether tivantinib is a beneficial treatment for your tumor.

Eligibility Criteria, among others, include:

Participant must be > 12 months and < 21 years of age at the time of study enrollment.
Participant must have a relapsed or refractory solid tumor, including CNS tumors.
Participant has fully recovered from the acute toxic effects of all prior anti-cancer therapy.
Participant has not received prior therapy with tivantinib.
Participant is not currently receiving another investigational drug.
Participant does not have an uncontrolled infection.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Wayne Furman, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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