UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014981 |
|---|---|
| Receipt number | R000017433 |
| Scientific Title | Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutation |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2014/08/28 16:21:08 |
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Basic information
Public title
Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutation
Acronym
Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutation
Scientific Title
Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutation
Scientific Title:Acronym
Phase 2 study of afatinib in patients with previously treated advanced non-sq NSCLC haboring EGFR mutation
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of afatinib in patients with previously treated advanced NSCLC haboring EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Overall survival
Safety
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
Afatinib 40mg/day
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically and/or cytologically proven NSCLC
2) Unresectable clinical stage IIIB/IV
3) Measurable or evaluable disease for RECIST 1.1
4) Patients who have sensitive EGFR mutation (exon19 deletion, exon21 L858R)
5) Previous treated with platinum combination chemotherapy
6) Patients who have never treated with EGFR-TKI
7) PS (ECOG): 0-2
8) Age: over 20, under 75
9) Adequate organ functions judged by laboratory tests
10) Interval of operation: 4 weeks after operation
11) Life expectancy: over 3 months
12) Written informed consent
Key exclusion criteria
1) Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc)
2) Age 20-74 years old
3) Patients who have previously treated with EGFR-TKI
4) Platinum combination chemotherapy naive
5) Patient with much ascetic fluid, pleural effusion, cardiac effusion.
6) Patient with active infection
7) Considered as unfit to study drug administration by attending doctor according to clinical symptomatic olthalmic disorder
8) Pregnancy
9) Symptomatic brain metastases
10) Patient with active double cancer (Exclude disease free interval over 5 years and carcinoma in situ)
11) Patients who have exon 20 T790M
12) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities.
13) Considered to be interfere to the agreement or understanding the protocol by attening doctor. Other ineligible status judged by attending doctor.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Graduate School of Medicine
Division name
Oncology Clinical Development
Zip code
Address
3-39-15, Shouwa-town, Maebashi-city, Gunma
TEL
027-220-8136
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Graduate School of Medicine
Division name
Oncology Clinical Development
Zip code
Address
3-39-15, Shouwa-town, Maebashi-city, Gunma
TEL
027-220-8136
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 08 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2014 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017433
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| Registered date | File name |
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