臨床研究等提出・公開システム

Date of registration	Jan. 06, 2021
Last modified on	Feb. 05, 2025
Trial ID	jRCT2031200286

Scientific Title	ONO-4578-04:Phase 1 study of ONO-4578 given as combinations of ONO-4578, ONO-4538 and modified FOLFIRINOX or Gem/nab-PTX in subjects with metastatic pancreatic cancer(ONO-4578-04)
Public Title	ONO-4578-04:ONO-4578 Phase 1 Study

Contact for Scientific Queries	Name	Namba Yoshinobu
	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		Jan. 16, 2021
Actual date of first enrollment		Jan. 13, 2021
Target sample size		60
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. Pancreatic invasive ducatal adenocarcinoma 2. Life expectancy of at least 3 months 3. 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	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		metastatic pancreatic cancer
Intervention(s)		ONO-4578 given as combinations of ONO-4578, ONO-4538 and modified FOLFIRINOX or Gem/nab-PTX
Primary Outcome(s)		Safety, tolerability

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	Dec. 28, 2020

Plan to share IPD	No

Secondary ID(s)	NCT06538207

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
10	Feb. 05, 2025	(this page)	Changes
9	Nov. 15, 2024	Detail	Changes
8	Sept. 29, 2024	Detail	Changes
7	Sept. 04, 2024	Detail	Changes
6	Mar. 03, 2023	Detail	Changes
5	Oct. 07, 2022	Detail	Changes
4	Feb. 10, 2022	Detail	Changes
3	July. 16, 2021	Detail	Changes
2	Mar. 30, 2021	Detail	Changes
1	Jan. 06, 2021	Detail

List of change history