ADVL0912: Phase I/II Study of Crizotinib, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and C-MET
Relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) with confirmed ALK fusion proteins, ALK mutations, ALK amplification, or MET mutation or amplification. If status is unknown, testing for ALK or MET can be performed to determine eligibility if clinically warranted.
Crizotinib is a small molecule inhibitor of c-MET kinase and ALK fusion protein, which both play a significant role in the pathogenesis of many cancers. Crizotinib has been shown to selectively inhibit proliferation of cells that express these proteins as well as induce cell death. Crizotinib will be given orally twice daily. The most commonly reported side effects include diarrhea, nausea and vomiting, and visual disturbances (e.g. shadows, streaking, flashing lights).
- Patients must be > 12 months and ≤ 21 years of age
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and have surpassed the required waiting period from recent therapies (varies greatly depending on type of therapy; contact study team for specific time lines).
- Must not have received any prior therapy with Crizotinib.
- Must have adequate bone marrow, renal, liver, and cardiac function.
- Must be able to swallow capsules or oral solution.
- Must not be receiving any medications that are inhibitors or inducers of CYP3A isozymes or CYP3A4 substrates with narrow therapeutic indices.
- Patients must not have any known interstitial fibrosis or interstitial lung disease.
- No history of myocardial infarction or cerebrovascular accident.
- Patients with CNS tumors or known CNS metastases are not eligible.
For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at firstname.lastname@example.org.