UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044627
Receipt number R000050975
Scientific Title Association of osimertinib induced dry skin with stratum corneum lipids change and blood level
Date of disclosure of the study information 2021/06/23
Last modified on 2021/06/23 10:12:15

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Basic information

Public title

Association of osimertinib induced dry skin with stratum corneum lipids change and blood level

Acronym

Association of osimertinib induced dry skin with stratum corneum lipids change and blood level

Scientific Title

Association of osimertinib induced dry skin with stratum corneum lipids change and blood level

Scientific Title:Acronym

Association of osimertinib induced dry skin with stratum corneum lipids change and blood level

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Dermatology Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the association of dry skin induced by osimertinib with stratum corneum lipid change and blood levels

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Transepidermal water loss(TEWL), Analysis of
stratum corneum components and structure, blood concentration of osimertinib

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

100 years-old >=

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

Key exclusion criteria

1. Patients with a history of allergy for a component of osimertinib
2. Patients with a history of serious drug allergy
3. Patients with other serious complications
4. Patients who are in pregnancy or intend to get pregnant
5. Patients with orally steroid treatment
6. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians

Target sample size

40


Research contact person

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

+81-54-264-5771

Email

uchinot@u-shizuoka-ken.ac.jp


Public contact

Name of contact person

1st name Tomonobu
Middle name
Last name Uchino

Organization

University 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

+81-54-264-5771

Homepage URL


Email

uchinot@u-shizuoka-ken.ac.jp


Sponsor or person

Institute

Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka

Institute

Department

Personal name



Funding Source

Organization

University of Shizuoka

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka general hospital

Address

4-27-1 kitaando aoi-ku shizuoka-shi Shizuoka, Japan

Tel

054-247-6111

Email

chiken-sougou@shizuoka-pho.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

SGHIRB#2020084

Org. issuing International ID_1

Shizuoka general hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

静岡県立総合病院 臨床研究倫理委員会


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 23 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

2021 Year 01 Month 25 Day

Date of IRB

2021 Year 01 Month 25 Day

Anticipated trial start date

2021 Year 06 Month 23 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

On the day of taking osimertinib (Day 0), on days 7, 14, 28, and 56 from the start of administration, the blood are collected. On same days, the stratum corneum is collected from inner forearm with tape stripping method after measurement of transepidermal water loss.
From the obtained sample, blood osimertinib concentration, CYP3A gene polymorphism, stratum corneum intercellular lipid component and structure are analyzed.

Association of the data obtained and clinical symptoms will be investigated.


Management information

Registered date

2021 Year 06 Month 23 Day

Last modified on

2021 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name