UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047903 |
|---|---|
| Receipt number | R000054614 |
| Scientific Title | Translational research of "A multicenter Phase II basket study of Brigatinib in patients with ALK fusion gene-positive advanced/recurrent solid tumors" |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2025/03/28 14:26:37 |
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Basic information
Public title
Translational research of "A multicenter Phase II basket study of Brigatinib in patients with ALK fusion gene-positive advanced/recurrent solid tumors"
Acronym
WJOG15221MTR
Scientific Title
Translational research of "A multicenter Phase II basket study of Brigatinib in patients with ALK fusion gene-positive advanced/recurrent solid tumors"
Scientific Title:Acronym
WJOG15221MTR
Region
| Japan |
Condition
Condition
ALK fusion gene positive advanced/recurrent solid tumors except for non-small cell lung cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers for therapeutic efficacy and resistance mechanisms of brigatinib therapy in patients with Anaplastic lymphoma kinase (ALK) fusion gene positive solid tumors.
Basic objectives2
Others
Basic objectives -Others
Biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To explore biomarkers for therapeutic efficacy and resistance mechanisms of brigatinib therapy in patients with Anaplastic lymphoma kinase (ALK) fusion gene positive solid tumors.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Explore biomarkers for therapeutic efficacy and resistance mechanisms of brigtinib in ALK fusion gene-positive advanced or recurrent solid tumors using tumor tissue and blood samples
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
Patients enrolled in the "multicenter phase II basket study of brigatinib in patients with ALK fusion gene positive advanced/recurrent solid tumors" who would provide written consent for the study will be eligible.
Key exclusion criteria
None
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi, Japan
TEL
052-762-6111
tmasuishi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Mizushima |
Organization
West Japan Oncology Group
Division name
Secretariat
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
mizushima@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi, Japan
Tel
052-762-6111
irb@aichi-cc.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To explore biomarkers for therapeutic efficacy and resistance mechanisms of brigatinib therapy in patients with Anaplastic lymphoma kinase (ALK) fusion gene positive solid tumors.
Management information
Registered date
| 2022 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054614
