UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054805 |
|---|---|
| Receipt number | R000062624 |
| Scientific Title | Phase Ia/Ib Basket Trial on the safety and efficacy of Mobocertinib in combination with T-DM1 for patients with HER2 mutant solid tumors Biomarker study (WJOG16022MTR) |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/12/27 09:11:50 |
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Basic information
Public title
Phase Ia/Ib Basket Trial on the safety and efficacy of Mobocertinib in combination with T-DM1 for patients with HER2 mutant solid tumors Biomarker study (WJOG16022MTR)
Acronym
WJOG16022MTR
Scientific Title
Phase Ia/Ib Basket Trial on the safety and efficacy of Mobocertinib in combination with T-DM1 for patients with HER2 mutant solid tumors Biomarker study (WJOG16022MTR)
Scientific Title:Acronym
WJOG16022MTR
Region
| Japan |
Condition
Condition
HER2 mutant solid tumors
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate exploratory biomarkers of mobocertinib in combination with T-DM1 for HER2 mutant solid tumors
Basic objectives2
Others
Basic objectives -Others
Biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate exploratory biomarkers of mobocertinib in combination with T-DM1 for HER2 mutant 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who were enrolled WJOG16022M
Subjects must have a signed and dated written informed consent form for exploratory use of tissue/blood samples
Key exclusion criteria
none
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Tanizaki |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL
072-366-0221
tanizaki_j@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
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
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai university institutional Review Board
Address
377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan
Tel
072-366-0221
tanizaki_j@med.kindai.ac.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
| 2024 | Year | 07 | Month | 10 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exploratory biomarker study to evaluate the association of mobocertinib plus T-MD1 efficacy and clinical background/characteristics of HER2 mutant solid tumors
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062624
