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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025126
Receipt No. R000028891
Scientific Title A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Date of disclosure of the study information 2016/12/03
Last modified on 2016/12/02

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Basic information
Public title A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Acronym A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Scientific Title A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Scientific Title:Acronym A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.
Region
Japan

Condition
Condition EGFR-T790M positive non-small-cell lung cancer relapsed after 3rd generation EGFR-TKI
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to investigate the utility of cell-free DNA for evaluating the mechanisms of resistance to 3rd generation EGFR-TKI, and the efficacy of afatinib treatment after relapsed 3rd generation EGFR-TKI
Basic objectives2 Others
Basic objectives -Others Detection of drug resistance mechanisms to 3rd generation EGFR-TKI in plasma cell-free DNA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of biomarker for afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment
Key secondary outcomes progression free survival, response rate, 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 Consecutively administer oral dose of afatinib at 40 mg/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

Not applicable
Gender Male and Female
Key inclusion criteria 1)EGFR mutation-poasitive lung adenocarcinoma
2)T790M mutation was detected after EGFR-TKI treatment, and refractory to 3rd generation EGFR-TKI
3)Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2
4)with evaluable lesion based on RESIST
5)written informed consent
Key exclusion criteria 1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer).
2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan.
3) Symptomatic brain metastasis (clinically stable brain metastasis is eligible)
4) HBs antigen-positive
5) Infection requiring systemic treatment
6) Patients who, in the opinion of the attending physician, are inappropriate for the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenobu Ishii
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7560
Email ishii_hidenobu@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenobu Ishii
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7560
Homepage URL
Email ishii_hidenobu@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Boehringer Ingelheim
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 03 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
2016 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 20 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
2016 Year 12 Month 02 Day
Last modified on
2016 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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