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Name:
UMIN ID:

Recruitment status No longer recruiting
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 2019/08/28

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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
Middle name
Last name Hiroaki Akamatsu
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL 073-441-0619
Email h-akamat@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email 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
Address
Tel
Email

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
2016 Year 08 Month 25 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 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 No longer recruiting
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
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.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


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