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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020370
Receipt No. R000023525
Scientific Title Phase 2 trial of the efficacy and safety of Afatinib for EGFR-TKI untreated EGFR gene mutation-Positive Elderly advanced or recurrent non-small cell lung Cancer. (APEC)
Date of disclosure of the study information 2015/12/27
Last modified on 2018/12/30

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Basic information
Public title Phase 2 trial of the efficacy and safety of Afatinib for EGFR-TKI untreated EGFR gene mutation-Positive Elderly advanced or recurrent non-small cell lung Cancer. (APEC)
Acronym Phase II trial of afatinib treatment for elderly non-small cell lung cancer patients with EGFR gene mutations
Scientific Title Phase 2 trial of the efficacy and safety of Afatinib for EGFR-TKI untreated EGFR gene mutation-Positive Elderly advanced or recurrent non-small cell lung Cancer. (APEC)
Scientific Title:Acronym Phase II trial of afatinib treatment for elderly non-small cell lung cancer patients with EGFR gene mutations
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of afatinib monotherapy for elderly non-small cell lung cancer patients with EGFR gene mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survval
Key secondary outcomes Safety, Respose rate, and overall survival

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 Daily 30mg of afatinib is orally administered until tumor progression or the onset of untolerable adverse events.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who are cytologically or histologically diagnosed with non-small cell clung cancer
2) Patients with non-small cell lung cancer harboring EGFR gene mutations (exon19 deletion, exon21 L858R, exon18 G719X, exon20 S768I, or exon21 L861Q) using tissue specimens or lavage fluid including pleural effusion
3) EGFR tyrosine kinase inhibitor-naive patients with the following stages
a) stage IIIA with pulmonary metastases
b) stage IIIB without indication of curative radiation therapy
c) stage IV
d) postoperative recurrence
4) Patients with measurable lesions acccording to RECIST criteria
5) Patients who are expected to survive more than 90 days from the time of enrollment
6) More than 75-year old patients at the time of enrollment
7) Patients who meet the following criteria
a) Neutrophil; more than 1,500/mm3
b) Platelet; more than 100,000/mm3
c) Hemoglobin; more than 9.0g/dL
d) Transaminases (AST and ALT); within 2.5XULN (institutional reference values)
e) Serum total bilirubin (T-Bil); within 1.5XULN
f) Serum creatinine (S-Cr); within 1.5XULN
g) PaO2 in arterial blood gas; more than 60Torr or SpO2; more than 90%
8) Performance status (ECOG) of 0-2
9) Patients who provide written informed consent for entry of this trial
Key exclusion criteria 1) Patients with active double cancers (simultaneous double cancers and metachronous double cancers with less than 5 years disease-free interval)
Exclusion: carcinoma in situ of cervix, gastric and colorectal cancers which can be radically resected by endoscope, and locally-resectable skin cancer except malignant melanoma
2) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography
3) Patients with symptomatic brain metastases
Exclusion: patients who have had stable symptoms more than 2 weeks after radiation therapy or more than 4 weeks after surgery
4) Patients with active infection
5) Patients requring continuous oxgen therapy
6) Patients who are in pregnancy or intend to get pregnant
7) Patients with a history of serious drug allergy
8) Patients with other serious complications
9) Patients with a history of allergy for a component of afatinib
10) Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons
11) Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Koyama
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Clinical Oncology
Zip code
Address 1163 Tatemachi, Hachioji-shi, Tokyo, 193-0998, Japan
TEL 042-665-5611
Email nkoyama@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutaka Watanabe
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Clinical Oncology
Zip code
Address 1163 Tatemachi, Hachioji-shi, Tokyo, 193-0998, Japan
TEL 042-665-5611
Homepage URL
Email yasuyasu@tokyo-med.ac.jp

Sponsor
Institute Saitama Lung Cancer Research Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 東京医科大学八王子医療センター(東京都)、自治医科大学附属さいたま医療センター(埼玉県)、春日部市立病院(埼玉県)、春日部中央総合病院(埼玉県)、川口市立医療センター(埼玉県)、埼玉県立循環器・呼吸器病センター(埼玉県)、さいたま赤十字病院(埼玉県)、草加市立病院(埼玉県)、東京医科大学八王子医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 27 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 Terminated
Date of protocol fixation
2015 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 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 12 Month 27 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023525

Research Plan
Registered date File name
2018/06/29 研究実施計画書0528.docx

Research case data specifications
Registered date File name
2018/06/29 Vol.1.1症例登録用紙(Afatinib).docx

Research case data
Registered date File name
2018/06/29 Vol.1.1症例登録用紙(Afatinib).docx


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