UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006892 |
|---|---|
| Receipt number | R000008129 |
| Scientific Title | Safety and feasibility of coadministration of erlotinib and Theracurmin (nanoparticle curcumin) in patients with advanced or recurrent non-small-cell lung cancer |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2011/12/13 16:08:10 |
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Basic information
Public title
Safety and feasibility of coadministration of erlotinib and Theracurmin (nanoparticle curcumin) in patients with advanced or recurrent non-small-cell lung cancer
Acronym
Safety and feasibility of coadministration of erlotinib and Theracurmin (nanoparticle curcumin) in patients with advanced or recurrent non-small-cell lung cancer
Scientific Title
Safety and feasibility of coadministration of erlotinib and Theracurmin (nanoparticle curcumin) in patients with advanced or recurrent non-small-cell lung cancer
Scientific Title:Acronym
Safety and feasibility of coadministration of erlotinib and Theracurmin (nanoparticle curcumin) in patients with advanced or recurrent non-small-cell lung cancer
Region
| Japan |
Condition
Condition
advanced or recurrent non-small-cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety and feasibility of Theracurmin combined with erlotinib in advanced or recurrent lung cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
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 | Food |
Interventions/Control_1
AdministrationofTheracurmin and erlotinib for 8 weeks. Dosage of erlotinib 150mg per day,Theracurmin, 3 cohorts, 180mg per day, 240mg per day, and 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 diagnosis of lung cancer
2)informed of lung cancer
3)compliant with oral medication
4)failure of standard treatments or first line erlotinib
5)PS 0-2
6)age over 20
7)approximately four weeks or more must pass from the prior treatment
8)Patients expected of 3 months or more survival
9)lesion that can be evaluated by RECIST
10) Adequate organ function
AST and ALT <=4 times the standard values
Total bilirubin <2.0mg/dL
Creatinine <2.0mg/dL
ECG normal
SpO2>90%
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
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yotaro Izumi |
Organization
School of Medicine, Keio University
Division name
Division of General Thoracic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Division of General Thoracic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2011 | Year | 12 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
| 2011 | Year | 12 | Month | 15 | Day |
Last modified on
| 2011 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008129
