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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
