UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028075
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

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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 or person

Institute

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

Institute

Department

Personal name



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

No longer 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 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 05 Day

Last modified on

2022 Year 07 Month 11 Day



Link to view the page

Value
https://center6.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