臨床研究等提出・公開システム

Date of registration	July. 05, 2024
Last modified on	Mar. 04, 2026
Trial ID	jRCT1011240022

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

Contact for Scientific Queries	Name	Masahide Fukudo
	Affiliation	Sapporo Medical University Hospital
	Address	South-1, West-16, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-11-688-9686
	E-mail	fukudom@sapmed.ac.jp
Contact for Public Queries	Name	Masahide Fukudo
	Affiliation	Sapporo Medical University Hospital
	Address	South-1, West-16, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-11-688-9686
	E-mail	fukudom@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 05, 2024
Target sample size		50
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects whose medical care and prognostic information can be obtained from medical records
	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.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Neoplasms (Lung Cancer etc.), Inflammatory Bowel Diseases, Rheumatoid Arthritis, Autoimmune Diseases
Health Condition(s) Code		D009369, D015212, D001172, D001327
Primary Outcome(s)		The variability of pharmacokinetics
Secondary Outcome(s)		-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

Primary Sponsor	Sapporo Medical University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Sapporo Medical University Hospital
Address	South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	June. 27, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 04, 2026	(this page)	Changes
1	July. 05, 2024	Detail

List of change history