臨床研究等提出・公開システム

Date of registration	June. 29, 2021
Last modified on	Nov. 15, 2024
Trial ID	jRCT2031210172

Scientific Title	ONO-7913-03:An open-label, uncontrolled study of ONO-7913 and ONO-4538 in combination with modified FOLFIRINOX as first-line treatment in patients with metastatic pancreatic cancer
Public Title	ONO-7913-03: ONO-7913 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	+81-120626190
	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	+81-120626190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2021
Actual date of first enrollment		July. 30, 2021
Target sample size		30
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	1. Untreated metastatic pancreatic cancer 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		Untreated metastatic pancreatic cancer
Intervention(s)		Administration of ONO-7913 and ONO-4538 in combination with mFFX therapy
Primary Outcome(s)		Tolerability, safety

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Kanagawa Cancer Center Research Ethics Review Board
Address	2-3-2, Nakao, Asahi,Yokohama, Kanagawa
Telephone	+81-45-520-2222
Approval Status	Approval
Date of approval	July. 12, 2021

Plan to share IPD	No

Secondary ID(s)	NCT06532344

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	Nov. 15, 2024	(this page)	Changes
7	Nov. 12, 2024	Detail	Changes
6	Sept. 04, 2024	Detail	Changes
5	Feb. 16, 2023	Detail	Changes
4	Oct. 07, 2022	Detail	Changes
3	Nov. 12, 2021	Detail	Changes
2	Sept. 07, 2021	Detail	Changes
1	June. 29, 2021	Detail

List of change history