臨床研究等提出・公開システム

Date of registration	June. 17, 2021
Last modified on	Mar. 16, 2026
Trial ID	jRCT2011210017

Scientific Title	Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinoma
Public Title	Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinoma

Contact for Scientific Queries	Name	Hirotoshi Akita
	Affiliation	Hokkaido University Hospital
	Address	North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-706-5021
	E-mail	hdakita@med.hokudai.ac.jp
Contact for Public Queries	Name	Watanabe Yudai
	Affiliation	Hokkaido University Hospital
	Address	North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-706-7735
	E-mail	ds-8201a_jimu@pop.med.hokudai.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 17, 2021
Target sample size		52
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	20 years and over at the time of written informed consent Histologically confirmed recurrent and or metastatic salivary gland carcinoma No indication for curative treatment Tumor tissue or undryed glass specimen is available IHC 3 plus IHC 2 plus IHC 1 plus and or ISH plus Patient with measurable lesion by RECIST version 1.1 ECOG performance status of 0 or 1 Adequate organ function
	Exclusion Criteria	History and complication of myocardial infarction or congestive heart failure Prolonged QT interval Complication of Interstitial lung disease Active central nervous system metastasis Other active malignancies Prior treatment with ADC of Exatecan derivative Topoisomerase I inhibitor
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		HER2-expressing recurrent and/or metastatic salivary gland carcinoma
Intervention(s)		DS-8201a 100 mg for injection is infused intravenously every 21 days (19-23 days) at a dose of 5.4 mg / kg based on the body weight of the subject.
Health Condition(s) Keyword		HER2-expressing, salivary gland carcinoma, recurrent and/or metastatic
Intervention(s) Keyword		intravenously infusion, per body weight
Primary Outcome(s)		Objective Response Rate by the Independent Central Image Committee
Secondary Outcome(s)		Efficacy: Best percent change in sum of diameter for tumor Disease control rate Progression free survival Overall survival Objective response rate by Principal Investigators Safety

Source of Monetary Support	Daiichi Sankyo Company Limited
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hokkaido UniversityHospital Institutional Review Board
Address	North 14 West 5, Kita-ku, Sapporo, Hokkaido
Telephone	+81-11-706-7934
E-Mail	recjimu@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	Jan. 19, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
16	Mar. 16, 2026	(this page)	Changes
15	June. 20, 2025	Detail	Changes
14	Sept. 30, 2024	Detail	Changes
13	April. 08, 2024	Detail	Changes
12	April. 03, 2024	Detail	Changes
11	Mar. 28, 2024	Detail	Changes
10	Feb. 27, 2024	Detail	Changes
9	Feb. 07, 2024	Detail	Changes
8	Dec. 13, 2023	Detail	Changes
7	June. 22, 2023	Detail	Changes
6	Mar. 17, 2023	Detail	Changes
5	May. 19, 2022	Detail	Changes
4	May. 17, 2022	Detail	Changes
3	April. 14, 2022	Detail	Changes
2	Mar. 06, 2022	Detail	Changes
1	June. 17, 2021	Detail

List of change history