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 |
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
Phase II Study of Crizotinib in MET alteration+ NSCLC
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
Phase II Study of Crizotinib in MET alteration+ NSCLC
Japan |
Non-Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
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
Safety,Efficacy
Confirmatory
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Crizotinib, 250 mg BID
Cycles are defined as 28-day periods
20 | years-old | <= |
Not applicable |
Male and Female
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).
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.
29
1st name | Takashi |
Middle name | |
Last name | Seto |
National Kyushu Cancer Center
Department of Thoracic Oncology
811-1395
3-1-1 Notame, Minami-ku, Fukuoka
092-541-3231
setocruise@gmail.com
1st name | Kaname |
Middle name | |
Last name | Nosaki |
National Kyushu Cancer Center
Department of Thoracic Oncology
811-1395
3-1-1 Notame, Minami-ku, Fukuoka
092-541-3231
qqtg52xd@gmail.com
National Kyushu Cancer Center
Japan Agency for Medical Research and Development
Japanese Governmental office
National Kyushu Cancer Center Institutional Review Board
3-1-1 Notame, Minami-ku, Fukuoka
092-541-3231
601-nkcc-tiken@mail.hosp.go.jp
NO
2018 | Year | 03 | Month | 20 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 07 | Day |
2018 | Year | 03 | Month | 07 | Day |
2018 | Year | 03 | Month | 24 | Day |
2021 | Year | 07 | Month | 31 | Day |
2018 | Year | 03 | Month | 07 | Day |
2021 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035817
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