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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006459
Receipt No. R000007666
Scientific Title Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Date of disclosure of the study information 2011/10/03
Last modified on 2011/10/03

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Basic information
Public title Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Acronym Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Scientific Title Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Scientific Title:Acronym Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous and Non-Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Response Rate
Disease Control 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 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)StageIIIB/IV or postoperative recurrence of NSCLC
3)EGFR mutation (exon18,19,21) negative
4)Failed to prior chemotherapy or chemoradiotherapy(<3 regimens)
5)Measurable lesions(RECIST)
6)ECOG PS 0-2
7)Age>=20years
8)Expected survival over 3 months
9)Interval
i)Palliative radiation therapy
/More than 2 weeks
ii)Operation(except chest)
/More than 4 weeks
iii)Treatment of Brain metastasis
/More than 4 weeks
iv)Cranial nerves surgery
/More than 3 months
v)Thoracic drainage
/More than 2 weeks
vi)Incisional biopsy, Port detention, Measures against externally caused injury
/More than 2 weeks
vii)Aspiration cytology
/More than 1week
10)Adequate function of main organ
11)Provided written informed consent
Key exclusion criteria 1)Squamous cell carcinoma
2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans
3)
i)Brain metastasis expected bleeding
ii)Patients with untreated Brain metastasis
4)Undergoing prior EGFR-TKI treatment
5)Active severe comorbidity disease.
6)History of hemoptysis
7)Uncontrollable hypertension
8)History of gastrointenstinal perforation or diverticulitis or fistula
9)Scheduled operation
10)History of grave drug allergic reaction.
11)Active concomitant malignancy
12)Pregnant or breast-feeding females
13)Inappropriate patients for this study judged by the physicians
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Inoue
Organization Kitakyushu Municipal Medical Center
Division name Respiratory medicine
Zip code
Address 2-1-1 Basyaku, Kokurakita-ku, Kitakyushu, JPAN, 802-0077
TEL 093-541-1831
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taishi Harada
Organization Graduate school of medical science, Kyushu University
Division name Research Institute for disease of the Chest
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN, 812-8582
TEL 092-642-5378
Homepage URL
Email Harada-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
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 九州大学(福岡県)、北九州市立医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 03 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
2011 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 03 Day
Last modified on
2011 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007666

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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