臨床研究等提出・公開システム

Date of registration	Dec. 15, 2020
Last modified on	June. 21, 2024
Trial ID	jRCT2051200096

Scientific Title	ONO-4578-03:Phase 1 study of ONO-4578 given as monotherapy and combinations of ONO-4578 and ONO-4538 as sequential treatment (neoadjuvant therapy) after chemoradiation therapy in subjects with resectable advanced rectal cancer
Public Title	ONO-4578-03:ONO-4578 Phase 1 Study

Contact for Scientific Queries	Name	Hirashima Yoshinori
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Center Information Medical
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 15, 2020
Actual date of first enrollment		Jan. 20, 2021
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Rectal adenocarcinoma 2. Patients with ECOG performance status 0 or 1
	Exclusion Criteria	1. Patients with severe complication 2. Patients with multiple primary cancers
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Resectable rectal cancer
Intervention(s)		ONO-4578 and combinations of ONO-4578 and ONO-4538 as neoadjuvant therapy
Primary Outcome(s)		Safety, tolerability

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	National Hospital Organization Osaka National Hospital Institutional Review Board I
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka city, Osaka
Telephone	+81-6-6942-1331
Approval Status	Approval
Date of approval	Nov. 24, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	June. 21, 2024	(this page)	Changes
5	Sept. 16, 2022	Detail	Changes
4	Dec. 17, 2021	Detail	Changes
3	Aug. 11, 2021	Detail	Changes
2	Mar. 30, 2021	Detail	Changes
1	Dec. 15, 2020	Detail

List of change history