UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031623
Receipt number R000035817
Scientific Title Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer
Date of disclosure of the study information 2018/03/20
Last modified on 2021/10/08 12:20:03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer

Acronym

Phase II Study of Crizotinib in MET alteration+ NSCLC

Scientific Title

Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer

Scientific Title:Acronym

Phase II Study of Crizotinib in MET alteration+ NSCLC

Region

Japan


Condition

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the anti-tumor activity and safety of
single-agent crizotinib for the treatment of advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive NSCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Objective response rate as assessed by independent radiology review (IRR) in advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive NSCLC

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

Interventions/Control_1

Crizotinib, 250 mg BID
Cycles are defined as 28-day periods

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

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1) Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
2) Positive for MET exon 14 skipping mutation or high MET copy number of 7 or more as determined by a validated RT-PCR and/or NGS by a designated central testing laboratory (LC-SCRUM).
3) At least 1 measurable tumor lesion as per RECIST (version 1.1) that has not been irradiated.
4) Female or male, 20 years of age or older.
5) ECOG performance status 0-2.
6) Adequate organ function as defined by the following criteria:
1.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <2.5 x upper limit of normal (ULN), or AST and ALT <5 x ULN if liver function abnormalities are due to underlying malignancy;
2.Total serum bilirubin <1.5 x ULN;
3.Absolute neutrophil count (ANC) >1500/microL;
4.Platelets >50,000/microL;
5.Hemoglobin >8.0 g/dL;
6.Serum creatinine <2 x ULN.
7) Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
8) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
9) Agree to use effective contraception during the study period and for at least 90 days after the last dose of crizotinib (excludes surgically sterile male patients or surgically sterile or postmenopausal female patients).

Key exclusion criteria

Patients presenting with any of the following will not be included in the trial:
1) Current treatment on another therapeutic clinical trial.
2) Characterized ALK or ROS1-positive rearrangement
3) Prior therapy specifically directed against MET
4) Any prior treatment (chemotherapy, radiation or surgery) within 2 weeks prior to study entry.
5) Any > Grade 1 acute toxicity (except alopecia).
6) Symptomatic brain metastases.
7) Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease.
8) Known interstitial fibrosis or interstitial lung disease.
9) Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
10) Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec.
11) Pregnancy or breastfeeding.
12) Use of drugs or foods after study enrollment that are known potent CYP3A4 inhibitors.
13) Use of drugs after study enrollment that are known potent CYP3A4 inducers.
14) Use of drugs after study enrollment that are CYP3A4 substrates with narrow therapeutic indices.
15) Any other anti-cancer drugs are prohibited.
16) Evidence of active malignancy within the last 3 years.
17) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
18)Patients whom investigator judges to be inappropriate as a participant.

Target sample size

29


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Seto

Organization

National Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code

811-1395

Address

3-1-1 Notame, Minami-ku, Fukuoka

TEL

092-541-3231

Email

setocruise@gmail.com


Public contact

Name of contact person

1st name Kaname
Middle name
Last name Nosaki

Organization

National Kyushu Cancer Center

Division name

Department of Thoracic Oncology

Zip code

811-1395

Address

3-1-1 Notame, Minami-ku, Fukuoka

TEL

092-541-3231

Homepage URL


Email

qqtg52xd@gmail.com


Sponsor or person

Institute

National Kyushu Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Kyushu Cancer Center Institutional Review Board

Address

3-1-1 Notame, Minami-ku, Fukuoka

Tel

092-541-3231

Email

601-nkcc-tiken@mail.hosp.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 20 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

Completed

Date of protocol fixation

2018 Year 02 Month 07 Day

Date of IRB

2018 Year 03 Month 07 Day

Anticipated trial start date

2018 Year 03 Month 24 Day

Last follow-up date

2021 Year 07 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

2018 Year 03 Month 07 Day

Last modified on

2021 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name