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 |
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)
Phase I/II study of osimertinib with bevacizumab (WJOG8715L)
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)
Phase I/II study of osimertinib with bevacizumab (WJOG8715L)
Japan |
Lung Cancer
Hematology and clinical oncology |
Malignancy
NO
To assess the efficacy and toxicity of Osimertinib plus bevacizumab
Safety,Efficacy
Phase I,II
Phase I: safety
Phase II: progression-free survival
Overall response rate, time to treatment failure, survival time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
Osimertinib+bevacizumab
Osimertinib
20 | years-old | <= |
Not applicable |
Male and Female
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
1. Subjects with interstitial lung disease
2. Subjects with high risk of bleeding
3. Positive test for hepatitis B virus antigen
86
1st name | Hiroaki |
Middle name | |
Last name | Akamatsu |
Wakayama Medical University
Third Department of Internal Medicine
641-8509
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
073-441-0619
h-akamat@wakayama-med.ac.jp
1st name | Shinichiro |
Middle name | |
Last name | Nakamura |
West Japan Oncology Group
WJOG datacenter
556-0016
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
Astrazeneka
Profit organization
Wakayama Medical University Certified Review Board
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
073-441-0896
wa-rinri(at)wakayama-med.ac.jp
YES
jRCTs051180183
jRCT
2016 | Year | 08 | Month | 25 | Day |
Published
https://pubmed.ncbi.nlm.nih.gov/31085043/
87
Completed
2016 | Year | 08 | Month | 11 | Day |
2016 | Year | 10 | Month | 06 | Day |
2016 | Year | 10 | Month | 11 | Day |
2020 | Year | 09 | Month | 03 | Day |
2016 | Year | 08 | Month | 25 | Day |
2021 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027377