UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015094 |
|---|---|
| Receipt number | 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 09:04:35 |
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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
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
iwama@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017561
