臨床研究等提出・公開システム

Date of registration	Nov. 25, 2020
Last modified on	Nov. 15, 2024
Trial ID	jRCT2031200215

Scientific Title	ONO-4578-02: ONO-4578 phase I study An open-label, uncontrolled study of first-line combination therapy of ONO-4578 and ONO-4538 with standard therapy XELOX plus bevacizumab or FOLFOX plus bevacizumab in patients with unresectable, advanced or recurrent colorectal cancer
Public Title	ONO-4578-02: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	Medical Information Center
	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	Not Recruiting

Anticipated date of first enrollment		Nov. 20, 2020
Actual date of first enrollment		Jan. 13, 2021
Target sample size		36
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 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 are unable to swallow oral medications
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable colorectal cancer
Intervention(s)		ONO-4578 given as combinations of ONO-4578, ONO-4538, XELOX plus bevacizumab or FOLFOX plus bevacizumab
Primary Outcome(s)		Safety, tolerability

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Approval Status	Approval
Date of approval	Nov. 04, 2020

Plan to share IPD	No

Secondary ID(s)	NCT06547385

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	Nov. 15, 2024	(this page)	Changes
8	Aug. 06, 2024	Detail	Changes
7	June. 07, 2024	Detail	Changes
6	Jan. 30, 2024	Detail	Changes
5	Dec. 16, 2023	Detail	Changes
4	April. 16, 2022	Detail	Changes
3	Aug. 11, 2021	Detail	Changes
2	Mar. 30, 2021	Detail	Changes
1	Nov. 25, 2020	Detail

List of change history