UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023761 |
|---|---|
| Receipt number | R000027377 |
| Scientific Title | A phase I study of osimertinib with bevacizumab and randomized phase II study of osimertinib with or without bevacizumab in EGFR mutated, T790M positive patients who had progressed EGFR-TKIs. (WJOG8715L) |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2021/08/31 10:14:03 |
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Basic information
Public title
A phase I study of osimertinib with bevacizumab and randomized phase II study of osimertinib with or without bevacizumab in EGFR mutated, T790M positive patients who had progressed EGFR-TKIs. (WJOG8715L)
Acronym
Phase I/II study of osimertinib with bevacizumab (WJOG8715L)
Scientific Title
A phase I study of osimertinib with bevacizumab and randomized phase II study of osimertinib with or without bevacizumab in EGFR mutated, T790M positive patients who had progressed EGFR-TKIs. (WJOG8715L)
Scientific Title:Acronym
Phase I/II study of osimertinib with bevacizumab (WJOG8715L)
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and toxicity of Osimertinib plus bevacizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: safety
Phase II: progression-free survival
Key secondary outcomes
Overall response rate, time to treatment failure, survival time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Osimertinib+bevacizumab
Interventions/Control_2
Osimertinib
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 proven, advanced lung adenocarcinoma
2. Harbor with EGFR mutation
3. Radiological progression was confirmed after 1st/2nd EGFR-TKI, and T790M was confirmed.
4. With evaluable lesion per RECIST ver 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Key exclusion criteria
1. Subjects with interstitial lung disease
2. Subjects with high risk of bleeding
3. Positive test for hepatitis B virus antigen
Target sample size
86
Research contact person
Name of lead principal investigator
| 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
h-akamat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Astrazeneka
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 Certified Review Board
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-441-0896
wa-rinri(at)wakayama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051180183
Org. issuing International ID_1
jRCT
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 | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31085043/
Number of participants that the trial has enrolled
87
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
| 2016 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 03 | Day |
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 | 25 | Day |
Last modified on
| 2021 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027377
