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

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 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

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

Value
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