UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042663
Receipt number R000048484
Scientific Title A prospective study of relationship between osimertinib-induced QT prolongation and pharmacokinetics, pharmacogenetics
Date of disclosure of the study information 2020/12/05
Last modified on 2020/12/05 16:55:11

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Basic information

Public title

A prospective study of relationship between osimertinib-induced QT prolongation and pharmacokinetics, pharmacogenetics

Acronym

A study of relationship between osimertinib-induced QT prolongation and pharmacological factors

Scientific Title

A prospective study of relationship between osimertinib-induced QT prolongation and pharmacokinetics, pharmacogenetics

Scientific Title:Acronym

A study of relationship between osimertinib-induced QT prolongation and pharmacological factors

Region

Japan


Condition

Condition

Non-small cell lung cancer harboring EGFR mutation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Analysis of relationship between osimertinibinduced QT prolongation and pharmacological and genomic polymorphisms

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The relationship between amount of change for QT intervals after osimertinib administration and pharmacological factors

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

Interventions/Control_1

Osimertinib is continued until disease progression or unless severe adverse events.

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. Non-small cell lung cancer confirmed by histology or cytology.
2. Positive for EGFR mutation that is sensitive to osimertinib.
3. Unresectable advanced or recurrent disease.
4. Patient who is twenty-years old or more at the time of starting osimertinib therapy.
5. Performance status (ECOG criteria) is 0 to 2.
6. Patient who has measurable lesion or evaluable lesion.
7. Patient whose life time is expected 3 months or more.
8. Patient who has no severe organ function disorders, and whose laboratory test is satisfied following next criteria.
1) Neutrophil counts are 1,500/mm3 or more.
2) Platelet counts are 100,000/mm3 or more.
3) Hemoglobin value is 8.0g/dl or more.
4) AST, ALT values are until 2.5 times of upper limit of normal.
5) Total bilirubin value is until 2 mg/dl.
6) QTc interval is under 450 msec at electrocardiogram.
7) HbA1c is until 7.9%.
9. Patient who has given sufficient informed consent prior to enrollment in this study, and have obtained a consent document with a signature and date.

Key exclusion criteria

1. Patient who has symptomatic CNS metastasis.
2. Patient who has active synchronous cancer.
3. Patient who received osimertinib therapy before.
4. Patient who has interstitial lung disease.
5. Patient who has severe infection.
6. Positive for HBs antigen and/or HCV antibody.
7. Patient who has cardiovascular diseases, for example unstable angina, myocardial infarction, that have been developed within 3 months.
8. Patient who has cerebrovascular disease, for example cerebral infarction, that have been developed within 3 months.
9. Patient who has severe uncontrolled comorbidity.
10. Patient who is unable to participate in study due to psychological disorder.
11. Patient who has severe drug sensitivity or allergy.
12. Patient who takes medicine that affect CYP3A4 such as phenytoin, carbamazepine, rifampicin, phenobarbital, itraconazole, and macrolides.
13. Patient who has contraindication to osimertinib.
14. Pregnant, lactating women or women who may become pregnant, or men who wish to have children.
15. Patient who is inappropriate for conducting study safely.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroo
Middle name
Last name Ishida

Organization

Showa University Northern Yokohama Hospital

Division name

Division of Medical Oncology

Zip code

224-8503

Address

35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa

TEL

045-949-7000

Email

hishida@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Hiroo
Middle name
Last name Ishida

Organization

Showa University Northern Yokohama Hospital

Division name

Division of Medical Oncology

Zip code

224-8503

Address

35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa

TEL

045-949-7000

Homepage URL


Email

hishida@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University

Institute

Department

Personal name



Funding Source

Organization

Showa University

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

Showa University Research Administration Center

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

Tel

03-3784-8129

Email

ura-ec@ofc.showa-u.ac.jp


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

2020 Year 12 Month 05 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

Open public recruiting

Date of protocol fixation

2020 Year 08 Month 11 Day

Date of IRB

2020 Year 10 Month 16 Day

Anticipated trial start date

2020 Year 12 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 05 Day

Last modified on

2020 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048484


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name