UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009846
Receipt number R000010758
Scientific Title Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC
Date of disclosure of the study information 2013/01/31
Last modified on 2020/01/04 18:08:32

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Basic information

Public title

Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC

Acronym

Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib

Scientific Title

Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC

Scientific Title:Acronym

Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib

Region

Japan


Condition

Condition

ALK fusion gene positive NSCLC

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To analyse pharmacokinetics and pharmacogenetics of Crizotinib in Japanese patients with ALK fusion gene positive NSCLC

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the correlation polymorphisms of ABCB1 and CYP3A4/5 with steady state plasma concentration and adverse events of Crizotinib.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

To evaluate steady state plasma concentration of Crizotinib and its metabolites.
To analyse gene polymorphism.
To evaluate plasma concentration of Crizotinib and its metabolites at the time of occurence of severe adverse events.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Histlogically or cytologically confirmed ALK fusion gene positive NSCLC
2.Unresectable and metastatic NSCLC
3.The patient who is plan to receive Crizotinib therapy (250mg twice a day)

Key exclusion criteria

1. Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy.
2. Preexisting interstitial lung disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tomohide
Middle name
Last name Tamura

Organization

National Cancer Center Hospital

Division name

Thoracic Oncology

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

TEL

03-3542-2511

Email

ttamura@ncc.go.jp


Public contact

Name of contact person

1st name Yutaka
Middle name
Last name Fujiwara

Organization

National Cancer Center Hospital

Division name

Thoracic Oncology

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

TEL

03-3542-2511

Homepage URL


Email

yutakafu@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Cancer Fundation

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Hospital

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

Tel

03-3542-2511

Email

yutakafu@ncc.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

国立がん研究センター中央病院(東京)、国立がん研究センター東病院(千葉)、がん研究会有明病院(東京)、北海道医学部(北海道)、都立駒込病院(東京)、北里大学医学部(神奈川)、神奈川県循環器呼吸器病センター(神奈川)、名古屋大学医学部(愛知)、名古屋医療センター(愛知)、大阪市立総合医療センター(大阪)、兵庫県立がんセンター(兵庫)、島根大学医学部(島根)、久留米大学医学部(福岡)、熊本大学医学部(熊本)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 31 Day


Related information

URL releasing protocol

https://www.lungcancerjournal.info/article/S0169-5002(18)30683-4/fulltext

Publication of results

Published


Result

URL related to results and publications

https://www.lungcancerjournal.info/article/S0169-5002(18)30683-4/fulltext

Number of participants that the trial has enrolled

75

Results

We identified clinically significant AEs in 35% of 75 NSCLC patients.
We evaluated AEs and germline variations by target-gene panel sequencing.
These AEs were associated with nonsynonymous SNVs in EPHX1 and TCF7L2.
Germline multi-gene information might be useful for predicting AEs.

Results date posted

2020 Year 01 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Key inclusion criteria were as follows: advanced NSCLC patients harboring the ALK-fusion gene, those planned to receive 250mg of crizotinib twice daily or who were currently under crizotinib treatment,

Participant flow

A total of 78 patients were enrolled between March 2013 and October 2014.

Adverse events

Common events included elevated AST/ALT levels (37.5%), neutropenia (16.7%), ILD (12.5%), and thromboembolic events (12.5%), including pulmonary embolism (n=2) and deep vein thrombosis (n=1). There was one treatment-related death as a result of ILD.

Outcome measures

PK analysis and PGx analysis

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 22 Day

Date of IRB

2013 Year 01 Month 22 Day

Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date

2014 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2020 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name