Unique ID issued by UMIN | UMIN000028075 |
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Receipt number | R000031711 |
Scientific Title | A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma |
Date of disclosure of the study information | 2017/07/19 |
Last modified on | 2022/07/11 08:36:03 |
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
Japan |
Recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma.
Recurrent or refractory neuroblastoma
Hematology and clinical oncology | Pediatrics |
Malignancy
NO
The objectives of this study are to evaluate the tolerability and safety of this drug in Japanese patients with recurrent/refractory ALK-positive ALCL or recurrent/refractory neuroblastoma (phase I part) and its efficacy in Japanese patients with recurrent/refractory ALK-positive ALCL (phase II part).
Safety,Efficacy
Exploratory
Phase I,II
[Phase 1 part]
Dose-limiting toxicity
[Phase 2 part]
Response rate evaluated by the Central Evaluation Committee
[Phase 1 part]
Pharmacokinetics
Adverse events
Response rate evaluated by the investigators
[Phase 2 part]
Complete remission rate
Response period
Progression-free survival [PFS]
Event-free survival [EFS]
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
No need to know
1
Treatment
Medicine |
A multicenter, single group assignment, open label, phase I dose-escalation study followed by a phase II study.
This drug should be orally administered twice a day. It should be repeatedly administered, regarding 28 days as a cycle.Each cycle will be repeated every 28 days. The data cutoff is carry out at 6 cycles for the phase 1 part and 12 cycles for the phase 2 part.
1 | years-old | <= |
22 | years-old | > |
Male and Female
[Phase 1/2 parts]
1)Patients aged 1 to 21 years on obtaining informed consent.
3)Patients whose histopathology tissues or slides of lymphoma can be provided for central review.
5)Patients aged over17 years with a Karnofsky performance status of 50 to 100% or those aged under16 years with a Lansky performance status of 50 to 100%.
6)Patients fully recovered from the acute toxic effects of all prior anti-cancer therapy, and enough periods defined in the protocol must have elapsed since the completion of each prior therapy.
7)Patients who fulfill the organ function requirement defined in the protocol.
[Phase 1 part]
2)Patients with recurrent/refractory ALK(+)ALCL or recurrent/refractory neuroblastoma, histologically confirmed at original diagnosis or relapse.
4)Patients with ALK(+)ALCL having measurable or evaluable disease, or patients with neuroblastoma having measurable tumor on MRI, CT, or plain X-ray or evaluable lesions by MIBG scintigraphy and/or bone marrow involvement with tumor cells seen on routine morphology.
[Phase II part]
2)Patients with recurrent/refractory ALK(+)ALCL histologically confirmed at original diagnosis or relapse.
4)Patients having measurable disease.
[Phase 1/2 parts]
1) Patients with CNS (central nervous system)disease.
2) Primary cutaneous ALCL.
3) Pregnant or brest-feeding women.
4) Patients of reproductive potential who have not agreed to use an effective contraception method.
5) Patients receiving the following concomitant medications
5-1) Therapeutic corticosteroids for lymphoma
5-2) investigational instruments and clinical trial products.
5-3) Anticancer agents
5-4) narrow therapeutic indice CYP3A4 substrates
5-5) Strong CYP3A4 inhibitors
5-6) Strong CYP3A4 inducers
6) Patients with interstitial fibrosis or interstitial lung disease or with a known history of those.
7) Patients with myocardial infarction or cerebrovascular disorder or with a known history of those.
8) Patients having an uncontrolled infectious disease.
9) Those who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
10) Patient who can not take capsule formulation or liquid formulation. However, administration of the liquid preparation via the feeding tube is permitted.
23
1st name | Tetsuya |
Middle name | |
Last name | Mori |
St. Marianna University School of Medicine Hospital
Department of Pediatrics
2168511
2-16-1 Sugao, Kawasaki, Miyamae-ku, Kanagawa, Japan
044-977-8111
morite@marianna-u.ac.jp
1st name | Yutaka |
Middle name | |
Last name | Ito |
National Hospital Organization Nagoya Medical Center
Department of Clinical Research Management, Clinical Research Center
4600001
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
052-951-1111
study.office@nnh.go.jp
St. Marianna University School of Medicine Hospital
National Center for Child Health and Development
Nagoya Medical Center
Kyushu University Hospital
AMED
Government offices of other countries
JAPAN
Nagoya Medical Center
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
052-951-1111
study.office@nnh.go.jp
NO
聖マリアンナ医科大学病院(神奈川県)
国立成育医療研究センター(東京都)
名古屋医療センター(愛知県)
九州大学病院(福岡県)
2017 | Year | 07 | Month | 19 | Day |
Unpublished
No longer recruiting
2017 | Year | 07 | Month | 19 | Day |
2017 | Year | 08 | Month | 10 | Day |
2017 | Year | 10 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 06 | Month | 30 | Day |
2017 | Year | 07 | Month | 05 | Day |
2022 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031711
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