UMIN-CTR Clinical Trial

Public title

Analysis of the stratum corneum structure in the patients taking erlotinib
-Towards the investigation of the mechanism of skin rash by the development of erlotinib administration-

Acronym

Analysis of the stratum corneum structure in the patients taking erlotinib

Scientific Title

Analysis of the stratum corneum structure in the patients taking erlotinib
-Towards the investigation of the mechanism of skin rash by the development of erlotinib administration-

Scientific Title:Acronym

Analysis of the stratum corneum structure in the patients taking erlotinib

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology	Dermatology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Detail investigation of skin rash by the analysis of stratum corneum structure in the patients taking erlotinib

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Transepidermal water loss(TEWL), Analysis of
ceramide components, lateral structure of
stratum corneum

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Analysis of startum corneum of the patients
with orally administrating erlotinib

Erlotinib dose : 150mg (once daily)
The stratum corneum of patients will be removed by tape stripping method on day 0, 7, 28 and 56 after starting erlotinib therapy.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are histologically diagnosed with non-small cell clung cancer
2. Patinents who are recurrent or progressive non-small-cell lung cancer
3. More than 20-years olds patients at the time of enrollement
4. ECOG Performance status of 0-2
5. Patients who are possible oral ingestion
6. Patients who are expected to survive more than 3 months from the time of enrollment
7. Patients who provide written informed consent for entry of this trial
8. Having adequate bone marrow, liver, renal, and respiratory function
i. White blood cell; more than 3,000/mm3 (or Neutrophil; more than 1,500/mm3)
ii. Platelet; more than 100,000/mm3
iii. Hemoglobin; more than 9.0g/dL
iv. Serum total bilirubin (T-Bil); within 1.5XULN (institutional reference values)
v. Transaminases (AST and ALT); within 2.5XULN
vi. Serum total bilirubin (T-Bil); within 1.5XULN

Key exclusion criteria

1. Patients with a history of allergy for a component of erlotinib
2. Patients with a history of EGFR inhibitor treatment before erlotinib administration (except for the patients with gefitinib treatment before erlotinib administration)
3. Patients with a history of serious drug allergy
4. Patients with other serious complications
5. Patients with a history of serious drug allergy
6. Patients who are in pregnancy or intend to get pregnant
7. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
8. Patients with orally steroid treatment

Target sample size

20

Name of lead principal investigator

1st name	Tomonobu
Middle name
Last name	Uchino

Organization

Univercity of Shizuoka

Division name

Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,

Zip code

422-8526

Address

52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan

TEL

054-264-5771

Email

uchinot@u-shizuoka-ken.ac.jp

Name of contact person

1st name	Tomonobu
Middle name
Last name	Uchino

Organization

Univercity of Shizuoka

Division name

Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,

Zip code

422-8526

Address

52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan

TEL

054-264-5771

Homepage URL

Email

uchinot@u-shizuoka-ken.ac.jp

Institute

Department of clinical pharmaceutics, School of Pharmaceutical Sciences, Univercity of Shizuoka

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shizuoka general hospital

Address

4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan

Tel

054-247-6111

Email

chiken-sougou@shizuoka-pho.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

11

Day

Date of IRB

2014

Year

09

Month

29

Day

Anticipated trial start date

2014

Year

09

Month

29

Day

Last follow-up date

2021

Year

02

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

21

Day

Last modified on

2023

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023858