Unique ID issued by UMIN | UMIN000013424 |
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Receipt number | 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 15:14:44 |
Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Safety evaluation of coadministration of erlotinib and theracurmin in non-small cell lung cancer patients
Japan |
non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
Evaluation of the saftey of coadministration of erlotinib and theracurmin in advanced or recurrent non-small cell lung cancer patients
Safety
Phase I,II
safety
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Food |
AdministrationofTheracurmin and erlotinib for 8 weeks. Dosage of erlotinib 150mg per day,Theracurmin, 1 cohort, 360mg per day.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
6
1st name | |
Middle name | |
Last name | Mitsuo Nakayama |
Saitama Medical Center
general thoracic surgery
1981 Kamoda Kawagoe City, Saitama Prefecture
042-228-3459
30mnaka@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Mitsuo Nakayama |
Saitama Medical Center
general thoracic surgery
1981 Kamoda Kawagoe City, Saitama Prefecture
042-228-3459
30mnaka@saitama-med.ac.jp
Saitama Medical Center
Saitama Medical Center, Division of general thoracic surgery
Self funding
NO
2014 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2014 | Year | 03 | Month | 14 | Day |
2014 | Year | 04 | Month | 01 | Day |
2015 | Year | 03 | Month | 15 | Day |
2014 | Year | 03 | Month | 14 | Day |
2018 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015676
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