UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030164 |
|---|---|
| Receipt number | R000034450 |
| Scientific Title | Monitoring EGFR mutation status with cell-free DNA: a prospective exploratory analyses of phase Ib study of osimertinib plus ramucirumab in lung adenocarcinoma patients with EGFR T790M mutation |
| Date of disclosure of the study information | 2017/11/29 |
| Last modified on | 2021/06/03 09:30:08 |
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Basic information
Public title
Monitoring EGFR mutation status with cell-free DNA: a prospective exploratory analyses of phase Ib study of osimertinib plus ramucirumab in lung adenocarcinoma patients with EGFR T790M mutation
Acronym
Exploratory analyses of Phase Ib study of osimertinib with ramucirumab
Scientific Title
Monitoring EGFR mutation status with cell-free DNA: a prospective exploratory analyses of phase Ib study of osimertinib plus ramucirumab in lung adenocarcinoma patients with EGFR T790M mutation
Scientific Title:Acronym
Exploratory analyses of Phase Ib study of osimertinib with ramucirumab
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the utility of liquid biopsy with Osimertinib plus ramucirumab
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of EGFR T790M mutation during treatment
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 + ramucirumab
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) Those who participate in the phase Ib trial of osimertinib+ramucirumab, and can provide blood sample (mandatory) and tissue sample (optional).
2) Written informed consent was obtained.
Key exclusion criteria
None
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Koh |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL
073-441-0619
ykoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Akamatsu |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL
073-441-0619
Homepage URL
h-akamat@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly and Company
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
Wakayama Medical University
Address
811-1, kimiidera
Tel
+81734410619
wa-rinri@wakayama-med.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
| 2017 | Year | 11 | Month | 29 | 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
3
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
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 09 | 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 | 11 | Month | 29 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034450
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
