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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014710
Receipt No. R000017092
Scientific Title Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC
Date of disclosure of the study information 2014/08/01
Last modified on 2017/12/24

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Basic information
Public title Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC
Acronym Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI
Scientific Title Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLC
Scientific Title:Acronym Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI
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 Afatinib plus Bevacizumab in patients with EGFR-mutant NSCLC after acquired resistance to EGFR-TKI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival
Disease control rate
Overall survival
Safety

Base
Study type

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 30 mg/day everyday, and bevacizumab is injected at 15 mg/kg every 3 weeks until progressive disease.

If possible, rebiopsy is performed to confirm T790M status.

To evaluate the safety, the traetment of afatinib should be administered at 30 mg/day in initial 6 cases only at institute of Biomedical Reseach and Innovation. After the treatment of this 6 cases, Data and Safety Monitoring Committee will judge the trial proceeding, based on safety results of this 6 cases.
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 (except squamous hislotogy)
2)EGFR mutation positive
3)After acquired resistance to EGFR-TKI (briefly, SD>6 months, defined by Jackman criteria)
4)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT
5)Age: over 20
6)ECOG PS: 0-2
7)Adequate organ functions judged by laboratory tests
8)Life expectancy: over 3 months
9)Written informed consent
Key exclusion criteria 1)Obvious interstitial pneumonia or pulmonary fibrosis by chest CT
2)History of severe allergic reaction
3)Complications such as severe infection or severe comobidities
4)Uncontrolled pleural or pericardial effusion
5)Clinically significant heart disease
6)Uncontrolled hypertension
7)Uncontrolled diabate
8)Active multiple cancer
9)Squamous histology
10)Aparent invasion of main vessels
11)Clinically significant phycological problem
12)History of significant hemoptysis or respiratory bleeding
13)History of GI perfolation
14)non-curable bone fracture or severe injury
15)Planning surgery
16)Significant lung cavitation
17)Bleeding tendency
18)Uncontrolled thromboembolism
19)Prior therapy of EGFR-TKI+bevacizumab
20)History of Afatinib administration
21)Pregnancy
22)Inadequate patients whom physitians considered
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Email katakami@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Akito Hata
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Homepage URL
Email a-hata@fbri.org

Sponsor
Institute Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor HANSHIN Oncology Group
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 大阪府立成人病センター呼吸器内科(大阪府)京都桂病院呼吸器内科(京都府)、倉敷中央病院呼吸器内科(岡山県)、神戸市立医療センター中央市民病院呼吸器内科(兵庫県)、神戸市立医療センター西市民病院呼吸器内科(兵庫県)、神戸大学医学部附属病院呼吸器内科(兵庫県)、刀根山病院呼吸器腫瘍内科(大阪府)、先端医療センター総合腫瘍科(兵庫県)、兵庫県立がんセンター呼吸器内科(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 30 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017092

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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