UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027655 |
|---|---|
| Receipt number | R000031682 |
| Scientific Title | A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer |
| Date of disclosure of the study information | 2017/06/07 |
| Last modified on | 2020/06/08 10:45:50 |
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Basic information
Public title
A phase II study of osimertinib
in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Acronym
A phase II study of osimertinib
in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Scientific Title
A phase II study of osimertinib
in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Scientific Title:Acronym
A phase II study of osimertinib
in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and efficacy of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Safety, Response rate, Improvement rate of performance status, Overall survival
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
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) ECOG PS 2, 3, or 4
2) Pathologically confirmation of non squamous non-small-cell lung cancer
3) Advanced non-small-cell lung cancer
4) History of using first-generation or second-generation EGFR-TKI
5) EGFR mutation with T790M in exon 20
6) Aged 20 or more
7) Written informed consent
Key exclusion criteria
1) History of using third-generation EGFR-TKI
2) Uncontrolled symptomatic brain metastasis
3) Interstitial pneumonia or pulmonary fibrosis on imaging
4) QTc > 500 msec
5) Gastrointestinal disorder
6) Uncontrollable pleural effusion , ascites or pericardial effusion
7) Receiving the radiation therapy for chest
8) 28th or less days from the last dosage of immunocheckpoint therapy
9) Severe complication
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Haruyasu |
| Middle name | |
| Last name | Murakami |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
ha.murakami@scchr.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakashima |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
(+81)055-989-5222
Homepage URL
kazuhin@med.shimane-u.ac.jp
Sponsor or person
Institute
Division of Thoracic Oncology, Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional review board of Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
(+81)055-989-5222
irb@scchr.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
| 2017 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031682
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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