All-Patient General Drug Use Surveillance of Rozlytrek Capsule - Advanced or recurrent solid tumors with NTRK gene fusions -

All-Patient General Drug Use Surveillance of Rozlytrek Capsule - Advanced or recurrent solid tumors with NTRK gene fusions - - All-Patient General Drug Use Surveillance of Rozlytrek Capsule- Advanced or recurrent solid tumors with NTRK gene fusions -

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037833

Enrollment

200

Registered

2019-09-04

Start date

2019-09-04

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: All patients expected to receive Rozlytrek during the enrollment period

Exclusion criteria

Exclusion criteria: Advanced or recurrent solid tumor patients with ROS1 gene fusions expected to receive Rozlytrek during the enrollment period

Design outcomes

Primary

Measure	Time frame
Safety 1.Incidence of early symptoms of cognitive disorders and ataxia by type 2.Time of onset of early symptoms of cognitive disorders and ataxia (e.g., basic statistics) 3.Proportion of patients requiring action with respect to Rozlytrek (e.g., treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia 4.Outcome rate (e.g., recovered, improved) by action taken with Rozlytrek (interruption, discontinuation) at onset of cognitive disorder or ataxia 5.Incidence of ADRs by type (by MedDRA PT, by safety concern defined in the safety specification) 6.Presence of growth or developmental retardation in pediatric patients 7.Variables related to growth and developmental retardation (e.g., height, body weight, bone age) in pediatric patients Efficacy 1.Investigator-assessed response rate (Assess response using RECIST.) 2.Investigator-assessed response rate in patients with NTRK fusion gene mutations (Assess response using RECIST.)	—

Measure

Time frame

Safety 1.Incidence of early symptoms of cognitive disorders and ataxia by type 2.Time of onset of early symptoms of cognitive disorders and ataxia (e.g., basic statistics) 3.Proportion of patients requiring action with respect to Rozlytrek (e.g., treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia 4.Outcome rate (e.g., recovered, improved) by action taken with Rozlytrek (interruption, discontinuation) at onset of cognitive disorder or ataxia 5.Incidence of ADRs by type (by MedDRA PT, by safety concern defined in the safety specification) 6.Presence of growth or developmental retardation in pediatric patients 7.Variables related to growth and developmental retardation (e.g., height, body weight, bone age) in pediatric patients Efficacy 1.Investigator-assessed response rate (Assess response using RECIST.*) 2.Investigator-assessed response rate in patients with NTRK fusion gene mutations (Assess response using RECIST.*)

—

Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety science Dept.

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

Outcome results