UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015094
Receipt No. R000017561
Scientific Title PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Date of disclosure of the study information 2014/09/09
Last modified on 2021/03/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Acronym LOGIK1401
Scientific Title PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Scientific Title:Acronym LOGIK1401
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective Response Rate
Key secondary outcomes PS improvement rate
Safety
Progression Free Survival
Overall Survival

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 Alectinib, 300 mg orally administered twice daily
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) Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
2) Positive for ALK fusion gene by "immunohistochemistry (IHC) and fluorescence in-situ hybridisation (FISH)" or "RT-PCR"
3) ALK-TKI naive other than crizotinib
4) At least 1 measurable tumor lesion as per RECIST v1.1
5) Female or male, 20 years of age or older
6) ECOG performance status 2 to 4
7) Adequate organ function
8) Signed and dated informed consent
Key exclusion criteria 1) known interstitial fibrosis or interstitial lung disease
2) Evidence of active malignancy
3) Brain metastasis with disordered consciousness
4) Uncontrolled Grade >/=3 SVC syndrome, pericardial effusion, pleural effusion, ascites
6) Active infectious disease
7) Concurrent radiotherapy including lung field
Target sample size 17

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
2014 Year 09 Month 09 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
2014 Year 09 Month 02 Day
Date of IRB
2014 Year 09 Month 16 Day
Anticipated trial start date
2014 Year 09 Month 02 Day
Last follow-up date
2017 Year 09 Month 30 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 09 Month 09 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.