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

Not Applicable

Recruiting

• Conditions: Advanced or recurrent solid tumors with NTRK gene fusions

• Registration Number: JPRN-UMIN000037833
• Lead Sponsor: Chugai Pharmaceutical Co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Last Update Posted: 23 April 2024
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.*)