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

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

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

Masahiro Sekimizu
, Tomoo Osumi
, Reiji Fukano
, Yuhki Koga
, Akiko Kada
, Akiko M. Saito
, Tetsuya Mori

Research output: Contribution to journal › Article › peer-review

Abstract

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).

Original language	English
Pages (from-to)	431-436
Number of pages	6
Journal	Acta Medica Okayama
Volume	72
Issue number	4
Publication status	Published - 2018
Externally published	Yes

All Science Journal Classification (ASJC) codes

General Biochemistry,Genetics and Molecular Biology

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Sekimizu, M., Osumi, T., Fukano, R., Koga, Y., Kada, A., Saito, A. M., & Mori, T. (2018). 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. Acta Medica Okayama, 72(4), 431-436.

Sekimizu, Masahiro ; Osumi, Tomoo ; Fukano, Reiji et al. / 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. In: Acta Medica Okayama. 2018 ; Vol. 72, No. 4. pp. 431-436.

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title = "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",

abstract = "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).",

author = "Masahiro Sekimizu and Tomoo Osumi and Reiji Fukano and Yuhki Koga and Akiko Kada and Saito, \{Akiko M.\} and Tetsuya Mori",

note = "Publisher Copyright: {\textcopyright}2018 by Okayama University Medical School.",

year = "2018",

language = "English",

volume = "72",

pages = "431--436",

journal = "Acta Medica Okayama",

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Sekimizu, M, Osumi, T, Fukano, R, Koga, Y, Kada, A, Saito, AM & Mori, T 2018, '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', Acta Medica Okayama, vol. 72, no. 4, pp. 431-436.

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. / Sekimizu, Masahiro; Osumi, Tomoo; Fukano, Reiji et al.
In: Acta Medica Okayama, Vol. 72, No. 4, 2018, p. 431-436.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - Study protocol for a multicenter single-arm open-label trial

AU - Sekimizu, Masahiro

AU - Osumi, Tomoo

AU - Fukano, Reiji

AU - Koga, Yuhki

AU - Kada, Akiko

AU - Saito, Akiko M.

AU - Mori, Tetsuya

PY - 2018

Y1 - 2018

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AB - 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).

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Sekimizu M, Osumi T, Fukano R, Koga Y, Kada A, Saito AM et al. 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. Acta Medica Okayama. 2018;72(4):431-436.

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

Abstract

All Science Journal Classification (ASJC) codes

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