Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -

Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions - - Special Drug Use Surveillance of Rozlytrek Capsule in Pediatric Patients - Advanced or recurrent solid tumors with NTRK gene fusions -

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039670

Enrollment

Registered

2020-09-04

Start date

2020-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent solid tumors with NTRK gene fusions

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

murayamaayk@chugai-pharm.co.jp03-3281-6611

Outcome results