臨床研究等提出・公開システム

Date of registration	July. 03, 2020
Last modified on	June. 06, 2025
Trial ID	jRCT2080225264

Scientific Title	ONO-7912 Phase I Study A multicenter, open-label, uncontrolled study in pancreatic cancer (ONO-7912-01)
Public Title	ONO-7912 Phase I Study (ONO-7912-01)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO., LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Phone Number	+81-120278120
	E-mail Address	clinical_trial@ono-pharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO., LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Phone Number	+81-120278120
	E-mail Address	clinical_trial@ono-pharma.com

Recruitment Status	completed

Date of First Enrolment		Oct. 01, 2020
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	A multicenter, open-label, uncontrolled study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients diagnosed with invasive pancreatic ductal carcinoma determined as adenocarcinoma histologically or cytologically 2. Patients who received one regimen of chemotherapy including gemcitabine for pancreatic cancer. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Have a life expectancy of at least 90 days
	Exclusion Criteria	1. Patients in whom oxaliplatin, irinotecan, fluorouracil, or levofolinate calcium is contraindicated 2. Patients with clinically relevant diarrhea (including watery stools) 3. Patients with grade >=2 peripheral motor neuropathy or peripheral sensory neuropathy 4. Patients who have received ONO-7912
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Patients with pancreatic cancer refractory or intolerance to chemotherapy including gemcitabine
Intervention(s)		investigational material(s) Generic name etc : devimistat (ONO-7912) INN of investigational material : devimistat Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Tolerability, safety
Secondary Outcome		efficacy exploratory pharmacokinetics Overall response rate, disease control rate, overall survival

Primary Sponsor	ONO PHARMACEUTICAL CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Cancer Center Hospital IRB
Address of IRB	5-1-1 Tsukiji, Chuo-ku, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Sept. 14, 2020

Secondary ID No.	JapicCTI-205360
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	June. 06, 2025	(this page)	Changes
6	Mar. 05, 2025	Detail	Changes
5	Sept. 12, 2022	Detail	Changes
4	Mar. 25, 2022	Detail	Changes
3	Oct. 15, 2020	Detail	Changes
2	Oct. 14, 2020	Detail	Changes
1	July. 06, 2020	Detail

List of change history