An exploratory iNvestigation of rEal-World pharmacokinetics and TherApeutic drug monitoring-Guided personalized dosing of novel molEcular Targeted drugs

An exploratory iNvestigation of rEal-World pharmacokinetics and TherApeutic drug monitoring-Guided personalized dosing of novel molEcular Targeted drugs - NEWTARGET study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1011240022

Enrollment

Registered

2024-07-05

Start date

2024-07-05

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

Neoplasms (Lung Cancer etc.), Inflammatory Bowel Diseases, Rheumatoid Arthritis, Autoimmune Diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects whose medical care and prognostic information can be obtained from medical records

Exclusion criteria

Exclusion criteria: Subjects presenting with any of the following will be excluded from the study: 1. Subjects who requested non-participation in this study based on a published opt-out document. 2. Subjects who are participating in or interested in participating in other clinical trials during the study period.

Design outcomes

Primary

Measure	Time frame
The variability of pharmacokinetics	—

Secondary

Measure	Time frame
-Pharmacokinetic linearity across doses administered -The incidence of adverse events -Response to treatment (clinical response and clinical remission) -Treatment persistence rate -Exposure-safety relationship -Exposure-efficacy relationship	—

Contacts

Public ContactFukudo Masahide

Sapporo Medical University Hospital

fukudom@sapmed.ac.jp+81-11-688-9686

Outcome results