臨床研究等提出・公開システム

Date of registration	Nov. 03, 2023
Last modified on	April. 16, 2025
Trial ID	jRCT2031230429

Scientific Title	ONO-7475-04:A Phase1 study to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
Public Title	ONO-7475-04:A Phase1 study of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and ONO-7475 in combination with GnP in patients with pancreatic cancer

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

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 07, 2023
Actual date of first enrollment		Dec. 06, 2023
Target sample size		87
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patient with metastatic pancreatic cancer 2.Patients have an ECOG performance status of 0 to 1 3.Patients with a life expectancy of at least 6 months
	Exclusion Criteria	1.Patients are unable to swallow oral medications 2.Patients with severe complication
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		metastatic pancreatic cancer
Intervention(s)		ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and ONO-7475 in combination with GnP
Primary Outcome(s)		Safety and tolerability
Secondary Outcome(s)		Efficacy, pharmacokinetics and immunogenicity

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Kanagawa Cancer Center Institutional Review Board
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa
Telephone	+81-45-520-2222
Approval Status	Approval
Date of approval	Oct. 23, 2023

Plan to share IPD	No

Secondary ID(s)	NCT06532331

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	April. 16, 2025	(this page)	Changes
4	Nov. 15, 2024	Detail	Changes
3	Sept. 04, 2024	Detail	Changes
2	Jan. 26, 2024	Detail	Changes
1	Nov. 03, 2023	Detail

List of change history