UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014710 |
|---|---|
| Receipt number | 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 15:54:32 |
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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
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
a-hata@fbri.org
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017092
