Research

Solid Tumor and Lymphoma Treatment with PF-02341066 – Phases I and II

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

Protocol Description

This Phase I and II Children’s Oncology Group trial is studying the drug PF-02341066 in treating patients with relapsed or refractory solid tumors, central nervous system (CNS) tumors, neuroblastoma, anaplastic large cell lymphoma (ALCL) and anaplastic lymphoma kinase (ALK) fusion proteins, mutations or amplification. In the lab, PF-02341066 has demonstrated an ability to inhibit the proteins c-MET and ALK, both of which are believed to be important to the growth of cancer cells. Through this study, researchers are studying the side effects and effectiveness of PF-02341066.

Study Level: Phases I and II

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, ages 1 to 21, who have been diagnosed with a malignant solid tumor, CNS tumor, neuroblastoma, ALCL or an ALK condition that is resistant to treatment by any standard therapy.
Males: Ages 1 to 21 years
Females: Ages 1 to 21 years

Requirements
Treatment consists of up to 24, 28-day cycles in which participants receive twice-a-day doses of PF-02341066. Blood tests will also be done. Specific sampling requirements and dosages are determined by the participant’s specific condition and in which arm of the study he or she is enrolled.
Frequency of visits: weekly for therapy and tests
Duration: Up to 2 years

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL0912)
National Cancer Institute

Additional Resources
Study Description at National Institutes of Health