臨床研究等提出・公開システム

Date of registration	June. 15, 2021
Last modified on	Nov. 15, 2024
Trial ID	jRCT2051210038

Scientific Title	ONO-7913: ONO-7913 Phase 1 Study; An open-label, uncontrolled study of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
Public Title	ONO-7913-04: 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.co.jp
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.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2021
Actual date of first enrollment		Sept. 23, 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. Unresectable advanced or recurrent colorectal 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		Unresectable advanced or recurrent colorectal cancer
Intervention(s)		Administration of ONO-7913 and ONO-4538 with FOLFOX and Bevacizumab or Cetuximab
Primary Outcome(s)		Tolerability, safety

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	June. 15, 2021

Plan to share IPD	No

Secondary ID(s)	NCT06540261

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
10	Nov. 15, 2024	(this page)	Changes
9	Sept. 05, 2024	Detail	Changes
8	Sept. 04, 2024	Detail	Changes
7	Sept. 16, 2023	Detail	Changes
6	Aug. 02, 2022	Detail	Changes
5	Jan. 22, 2022	Detail	Changes
4	Jan. 17, 2022	Detail	Changes
3	Nov. 09, 2021	Detail	Changes
2	July. 29, 2021	Detail	Changes
1	June. 15, 2021	Detail

List of change history