UMIN-CTR Clinical Trial

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
Email	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
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	Wakayama Medical University Certified Review Board
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel	073-441-0896
Email	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
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

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