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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021802
Receipt No. R000025009
Scientific Title Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Date of disclosure of the study information 2016/04/12
Last modified on 2016/10/11

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Basic information
Public title Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Acronym Research for RET-TKI resistance in NSCLC harboring with RET fusion gene
Scientific Title Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Scientific Title:Acronym Research for RET-TKI resistance in NSCLC harboring with RET fusion gene
Region
Japan

Condition
Condition Advanced non-small-cell lung cancer harboring with RET fusion gene
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
Basic objectives2 Others
Basic objectives -Others To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene using clinical sample before and after alectinib
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To find out the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Written informed consent
2. Histologically or cytologically diagnosed NSCLC
3. Unresectable locally advanced or metastatic disease
4. Tumor samples test positive for a RET fusion gene
5. Testing negative for an EGFR mutation
6. Testing negative for an ALK fusion gene
Key exclusion criteria 1. Having previously received alectinib
2.Patients whom an investigator deems ineligible for participation in this study for some other reason.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Yano
Organization Cancer Research Institute, Kanazawa University
Division name Medical Oncology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL 076-265-2794
Email syano@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadaaki Yamada
Organization Cancer Research Institute, Kanazawa University
Division name Medical Oncology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL 076-265-2794
Homepage URL
Email tadaakiy@staff.kanazawa-u.ac.jp

Sponsor
Institute Cancer Research Institute, Kanazawa University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hokkaido University
National Cancer Center Hospital East
The Cancer Institute Hospital of JFCR
Tokyo University
Nagoya University Hospital
Hyogo Cancer Center
Okayama University Hospital
National Hospital Organization Kyushu Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学大学院医学系研究科(北海道)
国立がん研究センター東病院(千葉県)
がん研究会有明病院(東京都)
東京大学大学院医学系研究科(東京都)
名古屋大医学部附属病院(愛知県)
金沢大学附属病院(石川県)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
国立病院機構 九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 12 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information To elucidate the resistance mechanism to RET-TKI alectinib using DNA, RNA, and proteins derived from clinical samples in patients with non-small-cell lung cancer harboring with RET fusion gene

Management information
Registered date
2016 Year 04 Month 06 Day
Last modified on
2016 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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