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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014477
Receipt No. R000016841
Scientific Title Feasibility study of pemetrexed / bevacizumab / erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Date of disclosure of the study information 2014/07/04
Last modified on 2017/07/06

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Basic information
Public title Feasibility study of pemetrexed / bevacizumab / erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Acronym Feasibility Study of pemetrexed / bevacizumab / erlotinib
Scientific Title Feasibility study of pemetrexed / bevacizumab / erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Scientific Title:Acronym Feasibility Study of pemetrexed / bevacizumab / erlotinib
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer,
Non-Squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine recommended dose of Pemetrexed/Bevacizumab/Erlotinib in chemotherapy naïve patients with non- small cell lung cancer harboring EGFR mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Feasibility of Pemetrexed/Bevacizumab/Erlotinib
Key secondary outcomes Anti-tumor efficacy


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 If four or more of the 6-12 patients who had been originally allocated to the level 0 experienced DLT, additional 6-12 patients were enrolled to the level -1. If four or more patients experienced DLT at this level, we conclude there was no feasibility of this combination.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histology/cytology-proven non-squamous non-small cell lung cancer
2)Stage IIIB, IV and unsuitable for radiotherapy and postoperative recurrence
3)EGFR mutant patients(exclude T790M mutation)
4)With one or more measurable disease based on RECIST
5)Performance status(ECOG): 0-1
6)Age 20<80
7)Adequate organ function
8)Written informed consent
Key exclusion criteria 1) Interstitial pneumonia/lung fibrosis on chest X-ray
2) History of chest radiation therapy
3) History or complication of hemoptysis with 2.5ml per time or more and Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent.
4) Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging
5) Evidence of tumor invading segmental bronchus
6) Symptomatic brain metastasis
7) Active hepatic disease
8) Having serious complications
9) Uncontrolled ascites, pleural effusion or cardiac effusion
10) History of multiple malignancies within 3 years
11) Planning of surgery during the trial
12) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy, and
13) Having serious mental disorder
14) Previous drug allergy
15) Those judged to be not suitable by the attending physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Ichiki
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Email ichiki@kyumed.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masao Ichiki
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Homepage URL
Email ichiki@kyumed.jp

Sponsor
Institute National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Institute
Department

Funding Source
Organization National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine
Organization
Division
Category of Funding Organization Other
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 国立病院機構 九州医療センター呼吸器内科(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 04 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
2014 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 03 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 04 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016841

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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