UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004255 |
|---|---|
| Receipt number | 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 21:13:12 |
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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
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
oncolctr@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Outpatient Oncology Unit, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005071
