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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013424
Receipt No. R000015676
Scientific Title Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Date of disclosure of the study information 2014/04/01
Last modified on 2018/12/11

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Basic information
Public title Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Acronym Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Scientific Title Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Scientific Title:Acronym Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the saftey of coadministration of erlotinib and theracurmin in advanced or recurrent non-small cell lung cancer patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes safety
Key secondary outcomes

Base
Study type

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 Food
Interventions/Control_1 AdministrationofTheracurmin and erlotinib for 8 weeks. Dosage of erlotinib 150mg per day,Theracurmin, 1 cohort, 360mg per day.
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)histological,cytological diagnosis of non-small cell lung cancer
2)failure of previous treatment or 1st line erlotinib
3)compliant with oral medication
4)failure of standard treatments or first line erlotinib
4)lesion that can be evaluated by
RECIST
5)PS0to2
6)can be admitted for the first 2 weeks of treatment
7)age over 20
8)adequate general condition
9)Patients expected of 3 months or more survival
10)approximately four weeks or more must pass from the prior treatment
11)Written consent
Key exclusion criteria 1)idiopathic pulmonary fibrosis, interstitial pneumonia, radiation pneumonitis, drug related pneumonitis
2)plueral, peritoneal, or pericardial effusion requiring drainage
3)active infection
4)unable to take oral medication
5)symptomatic eye disorders
6)pregnant or lactating
7)symptomatic brain metastasis
8)other malignancies
9)uncontrolled diabetes
10) active complications
11)patients whom physicians judged to be unsuitable for enrollment for other reasons
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Nakayama
Organization Saitama Medical Center
Division name general thoracic surgery
Zip code
Address 1981 Kamoda Kawagoe City, Saitama Prefecture
TEL 042-228-3459
Email 30mnaka@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuo Nakayama
Organization Saitama Medical Center
Division name general thoracic surgery
Zip code
Address 1981 Kamoda Kawagoe City, Saitama Prefecture
TEL 042-228-3459
Homepage URL
Email 30mnaka@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center
Institute
Department

Funding Source
Organization Saitama Medical Center, Division of general thoracic surgery
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
2014 Year 04 Month 01 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
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2015 Year 03 Month 15 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015676

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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