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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017806
Receipt No. R000020634
Scientific Title Additional analysis of Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Date of disclosure of the study information 2015/06/04
Last modified on 2018/06/06

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Basic information
Public title Additional analysis of Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Acronym LOGiK1401-A
Scientific Title Additional analysis of Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Scientific Title:Acronym LOGiK1401-A
Region
Japan

Condition
Condition Non-Small Cell Lung Cance
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore the relationship between dose and safety/efficacy of alectinib in the patients who are enrolled onto LOGIK1401. LOGIK1401 is a Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC. The UMIN ID of LOGIK1401 is UMIN000015094.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To explore the relationship between dose and safety/efficacy of alectinib
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) Patients enrolled onto the Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC (UMIN000015094)
2) Patients whose plasma sample can be obtained at day 15
3) Patients providing written informed consent.
Key exclusion criteria Nothing particular
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Okamoto
Organization Kyushu University Hospital
Division name Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Zip code
Address 3-1-1 Maidashi ,Higashi-ku,Fukuoka,
TEL 092-642-5378
Email okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Iwama
Organization Graduate School of Medical Sciences, Kyushu University
Division name Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Zip code
Address 3-1-1 Maidashi,Higashi-ku,Fukuoka,
TEL 092-642-5378
Homepage URL
Email iwama@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To explore the relationship between dose and safety/efficacy of alectinib by evaluating PK/PD in the patients who are enrolled onto LOGIK1401. LOGIK1401 is a Phase II safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC (UMIN000015094).

Management information
Registered date
2015 Year 06 Month 04 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020634

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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