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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004255
Receipt No. R000005071
Scientific Title Phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment
Date of disclosure of the study information 2010/09/24
Last modified on 2014/03/22

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Basic information
Public title Phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment
Acronym BEST study
Scientific Title Phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment
Scientific Title:Acronym BEST study
Region
Japan

Condition
Condition Refractory or relapsed non-Squamous, non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine safety and efficacy in combination with erlotinib and bevacizumab for refractory or relapsed non-squamous, non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes PFS, OS, Disease Control Rate, AE

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 Erlotinib 150mg/day, oral daily
Bevacizumab 15mg/kg, intravenous q3W
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) Histologically or cytologically confirmed non-squamous NSCLC
2) Refractory or relapsed to prior chemotherapy or chemoradiotherapy (< 3 regimes)
3) Age >= 20 years
4) P.S.(ECOG) 0-2
5) Measurable lesions (RECIST)
6) Sufficient organ functions within two weeks.
Defined as:
1. neutrophil count >= 1000/mm3
2. platelet >= 75,000/mm3
3. hemoglobin >= 8.0 g/dl
4. AST and ALT <= 100IU/L
5. serum bilirubin level <= 2.0 mg/dl
6. serum creatinine level <= 2.0 mg/dl
7. SaO2 >= 90% (room air)
8. Urine protein <= 1+
7) Expected survival over 3 months
8) No major operation within 28 days
9) Provided written informed consent
Key exclusion criteria 1) History of using EGFR-TKI
2) Active infectious disease, active other severe diseases (uncontrollable hypertension, diabetes mellitus, cardiac disease, gastro-intestinal hemorrhage etc.)
3) Hemoptysis with 2.5mL or more
bleeding tendency
4) Radiological findings of cavity lesion and/or central lesion and/or tumor invasion to major vessels
5) Cardiac and/or brain infarction within 6 months
6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
7) Brain metastasis expected bleeding
8) Ineterstitial pneumonitis on Chest CT
9) Impossible oral ingestion
10) Pleural or pericardial effusion, or ascites requiring treatment
11) Inappropriate patients for this study judged by the physicians.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Yanagihara
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Shogoinkawahara-choSakyo-ku, Kyoto, Japan 606-8507
TEL 075-366-7500
Email kazuhiro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Yanagihara
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Shogoinkawahara-choSakyo-ku, Kyoto, Japan 606-8507
TEL 075-366-7500
Homepage URL
Email oncolctr@kuhp.kyoto-u.ac.jp

Sponsor
Institute Outpatient Oncology Unit, Kyoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 京都大学医学部附属病院(京都府)、神戸市立医療センター中央市民病院(兵庫県)、倉敷中央病院(岡山県)、兵庫県立尼崎病院(兵庫県)、滋賀医科大学(滋賀県)、京都医療センター(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially 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
2010 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 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
2010 Year 09 Month 22 Day
Last modified on
2014 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005071

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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