UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039670 |
|---|---|
| Receipt number | R000045249 |
| Scientific Title | Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions - |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2024/01/15 14:28:58 |
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Basic information
Public title
Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -
Acronym
Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -
Scientific Title
Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -
Scientific Title:Acronym
Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -
Region
| Japan |
Condition
Condition
Advanced or recurrent solid tumors with NTRK gene fusions
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Along with pediatric information from all-patient general drug use surveillance, the following will be calculated and described using appropriate statistical methods.
Safety
Presence of growth or developmental retardation (e.g., height, body weight, bone age) in pediatric patients
s
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following observations will be collected in the 12-month CRFs for new patients starting treatment during the enrollment period for this study.
12-month CRF
1)Institution information: Name of institution, department, date CRF completed, name of physician completing CRF
2)Patient demographics: Patient initials, age at treatment initiation, ID number, sex, reason for use of Rozlytrek, Rozlytrek treatment history, height, body weight, cancer type, performance status, stage, treatment line, presence of metastases, concurrent disease, previous disease
3)Treatment status: Rozlytrek treatment status (dose per administration, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation in patients who discontinued treatment)
4)Bone age: Whether measured, date measured, bone age, measurement method
5)Growth and developmental retardation: Date assessed, presence, investigator comments (e.g., results of cognitive and developmental testing, results of endocrine function testing)
6)Status after discontinuation of Rozlytrek (at end of 12-month observation)
Pediatric follow-up CRF
1)Institution information: Name of institution, department, date CRF completed, name of physician completing CRF
2)Patient demographics: Patient initials, age at treatment initiation, ID number, sex, height, body weight
3)Treatment status: Whether Rozlytrek used, Rozlytrek treatment status (dose per administration, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation in patients who discontinued treatment)
4)Bone age: Whether measured, date measured, bone age, measurement method
5)Growth and developmental retardation: Date assessed, presence, investigator comments (e.g., results of cognitive and developmental testing, results of endocrine function testing)
6)Status after discontinuation of Rozlytrek (at end of 12-month observation)
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients transferred from all-patient general drug use surveillance of Rozlytrek who were less than 15 years old when receiving their first dose of Rozlytrek in all-patient general drug use surveillance (enrollment in this study is not needed)
After all-patient general drug use surveillance is switched to prospective use notification, of patients planning to use Rozlytrek during the enrollment period forthis study, those who are less than 15 years old when receiving their first dose of Rozlytrek
Key exclusion criteria
None
Target sample size
10
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
1038324
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
1038324
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
| 2020 | Year | 09 | Month | 04 | 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
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | 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=R000045249
| Research Plan | |
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| Registered date | File name |
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