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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023710
Receipt No. R000027314
Scientific Title A multicenter, single arm phase 2 study to examine efficacy and cerebrospinal fluid transitivity of Osimertinib in leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutation
Date of disclosure of the study information 2016/10/01
Last modified on 2016/10/03

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Basic information
Public title A multicenter, single arm phase 2 study
to examine efficacy and cerebrospinal fluid transitivity of Osimertinib
in leptomeningeal carcinomatosis (LMC) patients
with non-small cell lung cancer harboring EGFR mutation
Acronym A phase 2 study of Osimertinib in LMC
Scientific Title A multicenter, single arm phase 2 study
to examine efficacy and cerebrospinal fluid transitivity of Osimertinib
in leptomeningeal carcinomatosis (LMC) patients
with non-small cell lung cancer harboring EGFR mutation
Scientific Title:Acronym A phase 2 study of Osimertinib in LMC
Region
Japan North America

Condition
Condition leptomeningeal carcinomatosis (LMC) patients with 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 The purpose of this study is to evaluate efficacy and safety of Osimertinib in patients with lung cancer harboring EGFR mutation and metastasis to leptomeningeal carcinomatosis. This study is also conducted as a translational research to evaluate transitivity ofOsimertinib.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Progression-free survival
2.Cerebrospinal fluid transitivity of osimertinib
Key secondary outcomes 1.ORR, DCR, OS, Safety profile
2.QOL Evaluation (EORTC QLQ-C30)
3.Change of neurological finding (Neurologogical exam)
4.CNS-RR,CNS-DCR,CNS-PFS
5.To explore a resistance factor

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 80 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.Patients with non-small cell lung cancer diagnosed histologically or cytologically (except SCC)
2.Patients with EGFR gene mutation
3.Patients who shows acquired EGFR-TKI resistance. Patients resistant to a regimen of EGFR-TKI + other drug can also be enrolled
4.Patients with documented EGFR exon 20 T790M mutation in any lesion when EGFR-TKI failure
5.Patients who are detected;
-cytologically positive in CSF
-EGFR gene mutation positive in CSF
If both negative image can be confirmed as LMC with;
1:findings of thickened dura mater
2:image with exudation of contrast medium
and attending doctor and clinical study officer as central review are confirmed.
6.For patients who received radiotherapy, time defined below has been passed from the last radiotherapy till their enrollment to the present study
[1]Radiotherapy to lung field - over 4 weeks
[2]Radiotherapy to whole brain or whole spinal marrow
7.Patients aged 20 years or more at informed consent
8.PS 0 to 2
9.Patients with maintaining sufficient functioning of major organs
10.Three weeks has passed since the last dose of cytotoxic anticancer drug
11.expected survival of not less than 3 months from start of the study treatment
12.Patients who were fully explained about the study and submitted written informed consent before enrollment
13.Desirably, patients have measurable or evaluable lesion according to definition in RECIST (Ver. 1.1), but this criterion is not mandatory.
Key exclusion criteria 1.Patients with interstitial pneumonia or lung fibrosis clearly demonstrated by chest CT
2.Patients with a history of serious drug allergy
3.Patients with any serious infectious disease or other serious concurrent medical condition (e.g., gastrointestinal hemorrhage)
4.Patients with high amount of or uncontrollable pleural effusion, ascites or pericardial effusion
-If patients treat synechia with anticancer drugs who can participate in the study
5.Patients with any clinically problematic heart disease (e.g., uncontrollable arrhythmia/angina, cardiac failure)
6.Patients with uncontrollable diabetes mellitus concurrently
7.Patients with active double cancer
8.Patients with any clinically problematic psychiatric disorder
9.Patients with untreated fracture (except compression fracture associated with osteoporosis) or severe wound
10.Pregnant, lactating or possibly pregnant female patients, or patients reluctant to take an effective contraceptive measure
11.Patients have immuno-checkpoint inhibitor as previous treatment
12.Other patients who, in the opinion of the investigator, are not eligible for participation in the present study for any reason
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Integrated Onclogy
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 0783045200
Email katakami@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Nanjo, Akito Hata
Organization Institute of Biomedical Research and Innovation
Division name Integrated Onclogy
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Homepage URL
Email a-hata@fbri.org

Sponsor
Institute HANSHIN
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 HANSHIN0216
Org. issuing International ID_1 HANSHIN
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 明石医療センター 呼吸器内科
大阪府立成人病センター 呼吸器内科
金沢大学附属病院 がんセンター
関西医科大学附属病院 呼吸器腫瘍内科
京都桂病院 呼吸器内科
倉敷中央病院 呼吸器内科
神戸大学医学部附属病院 呼吸器内科
先端医療センター 総合腫瘍科
宝塚市立病院 腫瘍内科
刀根山病院 呼吸器腫瘍内科
兵庫県立がんセンター 呼吸器内科

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 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 22 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027314

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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