UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017806 |
|---|---|
| Receipt number | 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 09:33:03 |
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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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020634
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
