UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040562 |
|---|---|
| Receipt number | R000046273 |
| Scientific Title | Brigatinib biomarker study for ROS1-fusion positive cancer |
| Date of disclosure of the study information | 2020/05/28 |
| Last modified on | 2020/05/28 10:44:55 |
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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
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
takikeda@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046273
