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

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 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


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

Value
https://center6.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