A Phase I/II Study of PF-02341066, An Oral Small Molecule Inhibitor Of Anaplastic Lymphoma Kinase (ALK) And C-Met, In Children With Relapsed/Refractory Solid Tumors And Anaplastic Large Cell Lymphoma

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Research

Protocol

ADV912: A Phase I/II Study of PF-02341066, An Oral Small Molecule Inhibitor Of Anaplastic Lymphoma Kinase (ALK) And C-Met, In Children With Relapsed/Refractory Solid Tumors And Anaplastic Large Cell Lymphoma

Diseases

Leukemias / Lymphomas : Relapses/refractory solid tumors and anaplastic large cell lymphoma

Description

This is a Phase 1/2 study of a drug called PF-02341066. PF-02341066 is a drug that in laboratory studies can block or inhibit two proteins called c-met and Alk. These proteins may be important in the growth of certain types of cancer cells. PF-02341066 is considered experimental because the Food and Drug Administration (FDA) have not approved it.

The purpose of such studies (Phase I studies) is to find the largest dose of the drug that can be given safely to children and young adults, and to learn what its side effects are. This study uses PF-02341066 because it seems to work against cancer in test tubes and animals. The study teams of doctors do not know if PF-02341066 will work in children. PF-02341066 has been used in only a small number of adults. There is no guarantee that research participants who take part in this study will benefit from the experimental treatment.

Objectives

To find the highest safe dose of PF-02341066 that can be given without causing severe side effects;
To learn what kind of side effects PF-02341066 can cause;
To learn more about the pharmacology (how your body handles the drug) of PF-02341066;
To learn more about the biology of PF-02341066;
To determine whether PF-02341066 is a beneficial treatment for your tumor.

Eligibility

Patient should be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.
Patients with relapsed or refractory neuroblastoma and anaplastic larger cell lymphoma are eligible
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Patients who are currently receiving another investigational drug and patients with uncontrolled infection are not eligible.

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

John Sandlund, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

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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