UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037425 |
|---|---|
| Receipt number | R000042420 |
| Scientific Title | Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/01/20 11:28:36 |
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Basic information
Public title
Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors
Acronym
Biomarker study of HER2 basket study
Scientific Title
Biomarker sub study of the phase II study of trastuzumab and pertuzumab combination therapy for HER2 amplified advanced solid tumors
Scientific Title:Acronym
Biomarker study of HER2 basket study
Region
| Japan |
Condition
Condition
HER2 amplified solid tumor
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore genomic biomarkers for response of HER2 amplified advanced solid tumors to trastuzumab and pertuzumab combination therapy.
Basic objectives2
Others
Basic objectives -Others
biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships among genomic alterations and response
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
Participants of Phase II study
Written informed concent
Key exclusion criteria
According to Phase II study.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Sadakatsu |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical and Dental University
Division name
Cancer center
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo
TEL
03-3813-6111
her2.basket@gmail.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Ishibashi |
Organization
Tokyo Medical and Dental University
Division name
Medical Innovation center
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo
TEL
03-3813-6111
Homepage URL
her2.basket@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental university IRB
Address
1-5-45, yushima, bunkyo
Tel
03-3813-6111
tiken.crc@tmd.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
| 2019 | Year | 08 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected for the study as follows.
-cancer-related mutations (pre- and post-treatment)
-tumor response
Management information
Registered date
| 2019 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042420
