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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016507
Receipt No. R000019170
Scientific Title A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Date of disclosure of the study information 2015/02/10
Last modified on 2016/02/10

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Basic information
Public title A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Acronym A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Scientific Title A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Scientific Title:Acronym A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasibility and efficacy of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Adverse event, Response rate, Improvement rate of performance status, Overall survival

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 plus bevacizumab
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) Pathologically confirmation of non squamous non-small-cell lung cancer
2) EGFR mutation (exon 19 deletion or L858R in exon 21) proven
3) Stage IIIB/IV and chemo-naive non-small-cell lung cancer
4) ECOG PS 2 or 3
5) Evaluable lesions
6) Aged 20 or more
7) Adequate organ functions
8) Written informed consent
Key exclusion criteria 1) EGFR mutation with T790M in exon 20
2) Uncontrolled symptomatic brain metastasis
3) Hemoptysis
4) Bleeding tendency
5) Use of antithrombotic agents
6) Evidence of tumor invading major blood vessel
7) Cavitated tumor
8) Thrombosis
9) Interstitial pneumonia or pulmonary fibrosis on imaging
10) Gastrointestinal disorder
11) Uncontrollable pleural effusion , ascites or pericardial effusion
12) Past given the radiation therapy for chest
13) Active double cancer
14) Severe complication
15) History of severe allergy
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruyasu Murakami
Organization Shizuoka cancer center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL (+81)055-989-5222
Email ha.murakami@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Nakashima
Organization Shizuoka cancer center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL (+81)055-989-5222
Homepage URL
Email ka.nakashima@scchr.jp

Sponsor
Institute Shizuoka cancer center
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 静岡県立静岡がんセンター(静岡県)
広島市立広島市民病院(広島県)
関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 10 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
2015 Year 02 Month 10 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019170

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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