UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016444 |
|---|---|
| Receipt number | R000018275 |
| Scientific Title | A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2019/03/26 22:54:05 |
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Basic information
Public title
A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Acronym
A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Scientific Title
A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Scientific Title:Acronym
A phase 2 study of first line low dose afatinib in advanced non-small-cell lung cancer patients with mutated epidermal growth factor receptor
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of low dose afatinib in patients with EGFR-mutant NSCLC: Exon19 deletion or Exon 21 L858R mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival
Safety
Response rate
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 is prescribed at 20mg/day daily. If tolerated, this dose can be increased after 21 days of treatment.
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)Histological or cytological proven NSCLC
2)With sensitive EGFR mutation: Exon 19 deletion or Exon 21 L858R mutation
3)No indication for operation or radiation therapy
4)Chemotherapy-naive advanced or relapsed NSCLC
5)If after adjuvant or neoadjuvant chemotherapy: No molecular target drug
4 weeks after treatment without platinum agent
6)interval of radiation therapy: 1 weeks after thoracic RT
7)age: over 20
8)ECOG PS: 0-2
9)Adequate organ functions judged by laboratory tests
10)Life expectanancy: over 3 months
11)Written informed consent
Key exclusion criteria
1)obvious interstitial pneumonia or pulmonary fibrosis by chest CT
2)uncontrolled pleural or pericardial effusion
3)symptomatic brain metastasis
4)active multiple tumor
5)cannot take orally
6)obvious liver cirrhosis
7)clinically significant heart disease
8)infection which requires treatment
9)pregnancy
10)history of severe allergic reaction
11)anticontraceptive
12)inadequate patients whom physicians considered
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yoshioka |
| Middle name | |
| Last name | Hiroshige |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
hirotin@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Yokoyama |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ty14401@kchnet.or.jp
Sponsor or person
Institute
Kyoto Thoracic Oncology Research Group (KTORG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital
Address
1-1-1, Miwa, Kurashiki, Okayama
Tel
086-422-0210
igakuken@kchnet.or.jp
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 | 02 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018275
