A Phase I/II Study of Crizotinib for Recurrent or Refractory Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma and a Phase I Study of Crizotinib for Recurrent or Refractory Neuroblastoma: Study Protocol for a Multicenter Single-arm Open-label Trial

作者：Sekimizu Masahiro; Osumi Tomoo; Fukano Reiji; Koga Yuhki; Kada Akiko; Saito Akiko M.^*; Mori Tetsuya

来源：Acta Medica Okayama, 2018, 72(4): 431-436.

• crizotinib
• recurrent
• refractory
• anaplastic large cell lymphoma
• neuroblastoma

Crizotinib is an inhibitor of multiple tyrosine kinases, including the anaplastic lymphoma kinase (ALK). Responses to crizotinib have also been reported in patients with ALK-positive anaplastic large-cell lymphoma (ALCL) and solid tumors with ALK-mutation, including neuroblastoma. Optimal treatment for patients with recurrent or refractory ALK-positive ALCL and neuroblastoma has not been established. There is a need to develop new drugs for these patients. The objectives of this trial are to evaluate the tolerability and safety of crizotinib in Japanese patients with recurrent/refractory ALK-positive ALCL or neuroblastoma (phase I) and its efficacy in recurrent/refractory ALK-positive ALCL (phase II).

• 出版日期2018-8