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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016904
Receipt No. R000019620
Scientific Title A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Date of disclosure of the study information 2015/03/24
Last modified on 2016/09/24

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Basic information
Public title A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Acronym A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
Scientific Title A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)
Scientific Title:Acronym A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)
Region
Japan

Condition
Condition Advanced non-squamous non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the efficacy and safety of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate, overall survival, safety

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 Patients receive erlotinib plus bevacizumab every three weeks, as long as patients do not apply to treatment discontinuation criteria, until the disease progresses.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All participants must meet the following criteria
1: Pathologically proven Non-Sq NSCLC
2: Radiographically measurable lesion
3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4: Stage 3B/4 NSCLC or recurrence disease without prior chemotherapy
5: Age more than 75 years
6: adequate organ function
Neutrophil count: more than 1,500/uL
Platelet count: more than 100,000/uL
Hemoglobin: more than 9.0 g/dL
Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range
Total bilirubin: less than 1.5mg/dL.
PaO2: more than 60 torr
Serum creatinine: less than 1.5mg/dL
7: Life expectancy of more than 12 weeks
8: Written informed consent
9:Sensitive EGFR mutation (exon19 deletion or exon21 L858R) confirmed by PCR
Key exclusion criteria Exclusion criteria are as follows
1: Squamous cell carcinoma
2: Active interstitial pneumonia identified by chest X-ray
3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC
4: Uncontrolled massive pleural effusion or cardiac effusion
5: Superior vena cava syndrome
6: Uncontrolled brain metastases
7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months
8: Severe infection
9: Pregnancy or lactation
10: Active concomitant malignancy
11: History of severe allergic reactions to drugs
12: Evidence of bleeding diathesis or hemoptysis
13: Current or previous history of cerebrovascular disease
14: Current or previous history of GI perforation
15: A history of chest irradaiation.
16: Exon T790M mutation detected by PCR
17: Severe and unstable medical comorbidities
18: Being unsuitable for receiving the study treatment, judged by attending physicians
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu Univ. School of Medicine
Division name Department of Internal medicine, second division
Zip code
Address Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichiro Suzuki
Organization Hamamatsu Univ. School of Medicine
Division name Department of Internal medicine, second division
Zip code
Address Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL 053-435-2111
Homepage URL
Email sesuzuki@hama-med.ac.jp

Sponsor
Institute Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
Institute
Department

Funding Source
Organization Department of Internal medicine, second division, Hamamatsu Univ. School of Medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 24 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 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
2015 Year 03 Month 24 Day
Last modified on
2016 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019620

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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