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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023823
Receipt No. R000027447
Scientific Title Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC
Date of disclosure of the study information 2016/11/01
Last modified on 2016/11/20

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Basic information
Public title Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC
Acronym Osimertinib in poor PS patients with T790M-positive advanced NSCLC
Scientific Title Osimertinib in pre-treated poor PS patients with T790M-positive advanced NSCLC
Scientific Title:Acronym Osimertinib in poor PS patients with T790M-positive advanced NSCLC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of osimertinib in poor PS NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Osimertinib 80 or 40 mg/day
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) Pathologically or cytologically diagnosedadvanced non-small-cell lung cancer
2) Harboring EGFR active mutaion
3) Radiological progression was confirmed after 1st or 2nd generation EGFR-TKI
4) T790M mutation was confirmed
5) 5th or more days from the last dosage of EGFR-TKI
6) Age over 20 years old
7) ECOG PS 2-4
8) With evaluable lesion
9) Major organ function is satisfaction on registration in date from 14 days
10) Written informed consent
Key exclusion criteria 1) Patients with active double cancer for 5years
2) Interstitial pneumonia
3) Poor oral intake
4) History of using immunocheckpoint therapy
5) History of taking osimertinib medication
6) The infection requiring systemic treatment
7) Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial
8) Patients with symptomatic brain metastases
9) Uncontrolled diabetes
10) Serious complications
11) Patients during systemic administration steroids therapy over 4weeks
12) Poor PS due to complication
13) A pregnant woman, a woman in breast-feeding
14-15) Patients with severe heart disease
16) Prior radiotherapy for primary or metastasis evaluable lesion
17) Patients with severe hypersensitivity
18) Patients with corneal ulcer
19) An inappropriate case judged by doctor in charge
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Isobe
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2580
Email isobeti@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukari Tsubata
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2580
Homepage URL
Email ytsubata@med.shimane-u.ac.jp

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization Astra Zeneca
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 01 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
2016 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2016 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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