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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000023761 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Lung Cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1. Subjects with interstitial lung disease
2. Subjects with high risk of bleeding 3. Positive test for hepatitis B virus antigen |
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Target sample size | 86 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | West Japan Oncology Group |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027377 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |