UMIN-CTR Clinical Trial

Basic information
Public title	Brigatinib biomarker study for ROS1-fusion positive cancer
Acronym	Barossa biomarker study
Scientific Title	Brigatinib biomarker study for ROS1-fusion positive cancer
Scientific Title:Acronym	Barossa biomarker study
Region	Japan

Condition
Condition	solid tumor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study is an adjunct study to basket study of brigatinib in patients with advanced solid tumors with ROS1 rearrangement, and the efficacy of brigatinib using patient samples (tumor tissue and plasma) enrolled in the study and clarify the molecular mechanism involved in resistance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the relationship between the gene abnormalities before, during, and after treatment with brigatinib and the therapeutic effect, and to explore the molecular mechanism related to the efficacy and resistance of brigatinib in ROS1 fusion gene-positive solid tumors.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Gene panel performance confirmation part: 1) Patients enrolled in prospective observational study to clarify genetic abnormalities in lung cancer and their clinicopathologic, molecular biological characteristics, and resistance mechanism of cancer therapeutic agents. 2) Secondary use of specimens by using a written consent document explaining prospective observational study to clarify genetic abnormalities in lung cancer and their clinicopathologic, molecular biological characteristics, and resistance mechanism of cancer therapeutic agents, And there are enough samples to carry out the genetic analysis of this study. 3) Patients with ROS1 rearrangement positive lung cancer or ROS1 rearrangement negative lung cancer Efficacy / resistance analysis part: 1) Cases registered in basket study of brigatinib in patients with advanced solid tumors with ROS1 rearrangement. 2) Among the subjects who obtained consent to provide samples for the accompanying study using the informed consent document of basket study of brigatinib in patients with advanced solid tumors with ROS1 rearrangement, There are enough samples to perform the analysis.
Key exclusion criteria	non
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Goto
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	kgoto@east.ncc.go.jp

Public contact
Name of contact person	1st name Takaya Middle name Last name Ikeda
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Homepage URL
Email	takikeda@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel	04-7133-1111
Email	irst@ml.res.ncc.go.jp

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	国立がん研究センター東病院、国立がん研究センター中央病院、九州がんセンター、岡山大学病院、鳥取大学、兵庫県立がんセンター、大阪市立総合医療センター、名古屋大学、静岡県立静岡がんセンター、新潟県立がんセンター新潟病院、北海道大学

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 28 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
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	Enrolling by invitation
Date of protocol fixation	2020 Year 02 Month 06 Day
Date of IRB	2020 Year 02 Month 12 Day
Anticipated trial start date	2020 Year 03 Month 03 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	This study is a observational study.

Management information
Registered date	2020 Year 05 Month 28 Day
Last modified on	2020 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046273