UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052965 |
|---|---|
| Receipt number | R000060274 |
| Scientific Title | General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy - |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/01/15 14:34:53 |
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Basic information
Public title
General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy -
Acronym
Phesgo general drug use-results surveillance (Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy)
Scientific Title
General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy -
Scientific Title:Acronym
Phesgo general drug use-results surveillance (Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy)
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the incidence of adverse drug reactions under the actual use status of Phesgo for combination subcutaneous injection MA, IN for unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main items
1)Site information: Name of site, name of department, date of CRF entry, name of physician who entered the CRF
2)Patient characteristics: Patient's initials, gender, pregnancy, identification number within a site, age at the start of treatment, reason for use (HER2 overexpression/gene amplification test), height, weight, performance status (ECOG PS), treatment line, site of cancer, primary lesion, site of metastasis, complication, medical history, switching from pertuzumab/trastuzumab combination therapy to this drug
3)History of prior treatment: Drug therapy, surgery/radiotherapy
4)Administration status: Dose of this drug per administration, date of administration, premedication, status at entry of CRF
5)Concomitant therapy: radiotherapy
6)Adverse events: Name of adverse event or abnormal test value, date of onset, worst grade, seriousness, treatment, outcome, date of outcome, causal relationship (this drug, others)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects to be registered: Patients with unresectable advanced or recurrent HER2-positive colorectal cancer who are scheduled to use this drug for the first time during the registration period or have progressed after cancer chemotherapy for the first time using this drug at sites that have concluded the contract for this investigation
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3273-0769
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
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
None
Address
None
Tel
None
None
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
| 2023 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060274
