UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015984 |
|---|---|
| Receipt number | R000018474 |
| Scientific Title | Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405) |
| Date of disclosure of the study information | 2014/12/18 |
| Last modified on | 2022/02/04 13:23:35 |
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Basic information
Public title
Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)
Acronym
Efficacy of crizotinib in alectinib-refractory patients; phase2 trial (OLCSG1405)
Scientific Title
Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)
Scientific Title:Acronym
Efficacy of crizotinib in alectinib-refractory patients; phase2 trial (OLCSG1405)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer harboring EML4-ALK
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of crizotinib in alectinib refractory patients with advanced non-small cell lung cancer harboring EML4-ALK fusion gene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Progression-free survival, overall survival, expression of EML4-ALK and MET, adverse events, quality of life, and survey using the care notebook
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 oral administration twice per day
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
Advanced non-small cell lung cancer confirmed by histological or cytological diagnosis.
EML4-ALK fusion gene is positive.
There is no treatment history with ALK inhibitors excluding alectinib. The treatment history with cytotoxic chemotherapy is unquestioned.
Disease stage is III/IV period which is postoperative recurrence or unavailable for surgery or radical irradiation.
Performance status (ECOG scale): 0-2
Key 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.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideko Isozaki |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7227
Homepage URL
h.isozaki325@gmail.com
Sponsor or person
Institute
Okayama Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Non
IRB Contact (For public release)
Organization
Address
Tel
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
岡山大学病院呼吸器（岡山県）
KKR高松病院（香川県）
下関市立市民病院（山口県）
福山市民病院 （広島県）
岡山赤十字病院（岡山県）
岡山医療センター（岡山県）
南岡山医療センター（岡山県）
岡山労災病院（岡山県）
岡山済生会病院（岡山県）
川崎病院（岡山県）
倉敷中央病院 （岡山県）
神戸赤十字病院（兵庫県）
津山中央病院（岡山県）
呉共済病院（広島県）
福山医療センター（広島県）
尾道市民病院（広島県）
中国中央病院（広島県）
山口宇部医療センター（山口県）
岩国医療センター（山口県）
香川労災病院（香川県）
住友別子病院（愛媛県）
愛媛県立中央病院（愛媛県）
四国がんセンター（愛媛県）
鳥取市民病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 18 | 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
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018474
