UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026669 |
|---|---|
| Receipt number | R000030552 |
| Scientific Title | A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2018/02/19 22:41:08 |
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Basic information
Public title
A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Acronym
A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Scientific Title
A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Scientific Title:Acronym
A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutation
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to confirm the therapeutic effect and safety in monotherapy of Osimeltinib, third generation EGFR-TKI for EGFR T790M gene mutation-positive advanced nonsmall cell lung cancer combined with cancerous pleurisy, and to search for biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Objective Response Rate, Overall Survival, Pleural effusion Progression Free Survival, QOL(EORTC-QLQ-LC13), Safety, Biomarkers of blood and pleural effusion(VEGF, FGF2, CXCL12, HGF)
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)Diagnosis of Stage4 NSCLC with malignant pleural effusion
2)Pleural effusion requiring at least manual drainage treatment
3)Cytology in pleural effusion is positive
4)Cases with at least one measurable lesion that can be evaluated with RECIST ver.1.1
5) EGFR-TKI susceptibility gene at diagnosis Positive mutation
EGFR gene mutation positive Example: with exon 19 deletion or L858R
Exclude double mutation cases with EGFR minor mutation
6) Cases with treatment with at least one or more first generation or second generation EGFR-TKI
Enable past history of cytokide anti-cancer drug
7) When progression of a pathological condition is imagewise observed from pretreatment
8)A case in which a case of T790M gene mutation positive was confirmed by an approved diagnostic method
9)When the registration age is over 20 years old
10)When the performance status (WHO Scale)is 0-2
11)When the following major organ abilities are held at the examination price within 7 days before registration
Number of neutrophils:1,500/mm3 or more
Platelet count:100,000/mm3 or more
Hemoglobin:9.0g/dl or more
AST(GOT), ALT(GPT):100IU/L or less
Total bilirubin:1.5mg/dL or less
Serum creatinine value:1.5mg/dl or less
12)Cases satisfying SpO2 more than 90% before pleural drainage
13)Cases in which survival can be expected for 12 weeks or more from the administration start date
14)In the case of men, for example, when using a contraceptive method using condoms
15)In case of a fertile woman, if appropriate contraceptive measures are taken
16)When consent is obtained from the patient himself for participation of this research
Key exclusion criteria
1) Patients with a history of severe allergy or hypersensitivity to the ingredients of the drugs used
2) Cases with pleurodesis
3) Case of treatment history of Osimeltinib and other third generation EGFR-TKI
4) Patients treated with immune checkpoint inhibitors
5) Cases with major surgery within 4 weeks
6) Patients who are concomitantly taking drugs with strong inducing action on cytochrome P450 (CYP) 3A4 or supplements of Chinese traditional herbs (or patients who can not be discontinued at least 1 week before the first dose)
7) Cases with complications of malignancy and / or other active malignant tumors requiring treatment within one year prior to the first dose
8) Cases with serious complications
9) Examples of symptomatic brain metastasis and spinal cord pressure exclusion (cases that can be controlled by treatment can be registered)
10) Cases with obvious interstitial pneumonia or pulmonary fibrosis in chest CT or cases with a history of interstitial pneumonia
11) Patients with a history of gastrointestinal resection such as refractory nausea and vomiting, chronic gastrointestinal disorder, inability to swallow or absorption possibly significantly affecting absorption of osimertinib
12) Case in which QTc value is 470 msec or more in electrocardiogram examination at screening
13) Case with corneal ulcer
14) Cases with difficult ingestion
15) Pregnant women or lactating women
16) Other cases, cases in which doctor in charge judged inappropriate as the subject of this study (examples where dementia patients or psychiatric patients are difficult to perform the test)
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
National hospital organization Kinki-chuo Chest Medical Center
Division name
thoracic oncology
Zip code
Address
1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL
072-252-3021
s-atagi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Sonobe |
Organization
National hospital organization Kinki-chuo Chest Medical Center
Division name
internal medecine
Zip code
Address
1180, nagasone-cho, kita-ku, sakai-city, osaka
TEL
072-252-3021
Homepage URL
sksonobe@kch.hosp.go.jp
Sponsor or person
Institute
The Japan-Multinational Trial Organization
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca plc
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
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 | 03 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 22 | 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
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030552
