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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015984 |
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Date of registration:
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18/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)
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Scientific title:
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Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405) - Efficacy of crizotinib in alectinib-refractory patients; phase2 trial (OLCSG1405) |
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Date of first enrolment:
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2014/12/18 |
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Target sample size:
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9 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018474 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Katsuyuki Kiura |
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Address:
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2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Japan |
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Telephone:
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086-235-7227 |
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Email:
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kkiura@md.okayama-u.ac.jp |
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Affiliation:
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Okayama University Hospital Department of Respiratory Medicine |
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Name:
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Hideko Isozaki |
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Address:
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2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Japan |
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Telephone:
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086-235-7227 |
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Email:
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h.isozaki325@gmail.com |
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Affiliation:
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Okayama University Hospital Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients with symptomatic brain metastases. Pregnant women, nursing mothers, the women who may be pregnant or have the will to get pregnant, and the men who hope for fertility with pregnancy. The patients with a history of hypersensitivity to crizotinib.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Non-small cell lung cancer harboring EML4-ALK
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Intervention(s)
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Crizotinib 250 mg oral administration twice per day
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Primary Outcome(s)
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Objective response rate
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Secondary Outcome(s)
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Progression-free survival, overall survival, expression of EML4-ALK and MET, adverse events, quality of life, and survey using the care notebook
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Source(s) of Monetary Support
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Non
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Okayama University
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Ethics review
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Status: YES
Approval date: 16/12/2014
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2019 |
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URL:
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