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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028075
Receipt No. 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 2019/03/25

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Basic information
Public 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
Acronym 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma.
Recurrent or refractory neuroblastoma
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes [Phase 1 part]
Dose-limiting toxicity
[Phase 2 part]
Response rate evaluated by the Central Evaluation Committee
Key secondary outcomes [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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
22 years-old >
Gender Male and Female
Key inclusion criteria [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.
Key exclusion criteria [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.
Target sample size 23

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Mori
Organization St. Marianna University School of Medicine Hospital
Division name Department of Pediatrics
Zip code 2168511
Address 2-16-1 Sugao, Kawasaki, Miyamae-ku, Kanagawa, Japan
TEL 044-977-8111
Email morite@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Ito
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Clinical Research Management, Clinical Research Center
Zip code 4600001
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Homepage URL
Email study.office@nnh.go.jp

Sponsor
Institute St. Marianna University School of Medicine Hospital
National Center for Child Health and Development
Nagoya Medical Center
Kyushu University Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya Medical Center
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
Tel 052-951-1111
Email study.office@nnh.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 19 Day
Date of IRB
2017 Year 08 Month 10 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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