ADVL0912, A Phase 1/2 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
PF-02341066 will be administered twice daily on days 1-28. A cycle of therapy is considered to be 28 days. Subjects may continue to receive PF-02341066 indefinitely unless serious side effects develop or their tumor worsens.
We plan to enroll three subjects on this study locally. A maximum of 45 subjects are anticipated to be enrolled from all COG Phase II institutions for Part A and another 45 subject for Part B and C. A subject can receive therapy for up to 24 months. Subjects will be followed for 30 days after the last dose of the investigational agent.
1. Patients must be > than 12 months and <= 21 years of age (<= 18 years of age at this institution) at the time of study enrollment.
2. Patients receiving the formulated capsule must have a BSA (phase 2) >= 0.63 at the time of study enrollment.
3. Patients must have had histologic verification of malignancy at original diagnosis or relapse.
a. Phase 2 (Part A2): Patients with diagnoses other than neuroblastoma or ALCL with confirmed ALK fusion proteins, ALK mutations, ALK amplification, or MET mutation or amplification.
b. Phase 2 (Part B)- Patients with neuroblastoma must have proven ALK+ disease with either measurable and/or evaluable disease
c. Phase 2 (Part C)- Patients must have proven ALK+ disease with either measurable or evaluable disease
5. Performance Level: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients <= 16 years of age.
6. Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
8. Patients must have adequate bone marrow, renal, cardiac and liver, function.
9. Patients must be able to swallow capsules or a liquid suspension/solution.
10. All patients and/or their parent or legal guardian must sign a written informed consent.
11. All institutional, FDA, and NCI requirements for human studies must be met.