UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026108 |
|---|---|
| Receipt number | R000030004 |
| Scientific Title | Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2019/08/19 11:28:41 |
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Basic information
Public title
Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Acronym
Study for acquired resistance mechanisms for afatinib using plasma samples
Scientific Title
Prospective study for clarification of mechanisms of acquired resistance for afatinib using plasma samples
Scientific Title:Acronym
Study for acquired resistance mechanisms for afatinib using plasma samples
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this prospective study is to determine the mechanisms of acquired resistance for afatinib as the first line treatment of non small cell lung cancer using plasma samples.
Basic objectives2
Others
Basic objectives -Others
The study is to determine relation of detected mutations from ctDNA before afatiib treatment by NGS and effect of afatinib. Furthermore the study is to determine relation of detected mutations from ctDNA at acquired resistance to afatinib by NGS and effect of osimertinib.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Examination of variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.
Key secondary outcomes
Examination of variety and rate of gene abnormality detected from ctDNA before and at the time of acquired resistance for afatinib.
Examination about correlation of gene abnormality detected from ctDNA and response rate, progression free survival and time to treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. StageIIIB or IV non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion, L858R, L861Q and G719X.
2. Patient is treated with afatinib as the first line therapy.
3. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1).
4. Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
5. Non-small cell lung cancer patients with written consent.
Key exclusion criteria
1. Previously treated with an EGFR TKI.
2. Previously treated with an immune checkpoint inhibitor.
3. Patients who, in the opinion of the attending physician, are inappropriate for the study .
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Aragane |
Organization
Saga Univ, Faculty of Medicine
Division name
Division of Hematology, Respiratory Medicine and Oncology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2369
sueokan@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Nakamura |
Organization
Saga Univ, Faculty of Medicine
Division name
Division of Hematology, Respiratory Medicine and Oncology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2369
Homepage URL
nakamurt@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Univ,Clinical research center
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
Clinical research center of saga university hospital
Address
5-1-1 Nabeshima, Saga, Japan
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.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
| 2017 | Year | 02 | Month | 13 | 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
29
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Variety and rate of gene abnormality detected from plasma at the time of acquired resistance for afatinib.
Management information
Registered date
| 2017 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030004
