UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Title of the study (Brief title)	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	Mitsuo Nakayama
Organization	Saitama Medical Center
Division name	general thoracic surgery
Address	1981 Kamoda Kawagoe City, Saitama Prefecture
TEL	042-228-3459
Email	30mnaka@saitama-med.ac.jp

Public contact
Name of contact person	Mitsuo Nakayama
Organization	Saitama Medical Center
Division name	general thoracic surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015676