臨床研究等提出・公開システム

Date of registration	Dec. 24, 2020
Last modified on	Dec. 24, 2020
Trial ID	jRCT2051200105

Scientific Title	Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F long-term administration in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy
Public Title	Phase I / IIa trial of R-OKY-034F long-term administration for pancreatic cancer patients

Contact for Scientific Queries	Name	Kusaka Haruki
	Affiliation	J-Pharma Co., Ltd.
	Address	75-1 Onocho, Tsurumi, Yokohama, 230-0046 JAPAN
	Telephone	+81-455061155
	E-mail	kusaka.h@j-pharma.com
Contact for Public Queries	Name	Kusaka Haruki
	Affiliation	J-Pharma Co., Ltd.
	Address	75-1 Onocho, Tsurumi, Yokohama, 230-0046 JAPAN
	Telephone	+81-45-506-1155
	E-mail	kusaka.h@j-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 17, 2019
Actual date of first enrollment		Sept. 17, 2019
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. Patients who are 20 years old or above at the time of informed consent 2. Patients with the ECOG performance status of 0 to 2 at the time of informed consent 3. Patients with a life expectancy of at least 90 days from the day of enrollment 4. Patients with a measurable lesion defined by the criteria of the RECIST version 1.1 according to the imaging during screening period 5. Patients judged by the (sub)investigator for whom the treatment may be continued R-OKY-034F-101 study
	Exclusion Criteria	1. Patients with active duplicate cancer 2. Patients with QTcE of over 500 msec 3. Patients weighing less than 40 kg at the time of informed consent 4. Patients who are considered inappropriate as a subject of this study by the (sub)investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic cancer
Intervention(s)		Once a day for orally 1mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg, 15 mg/kg
Primary Outcome(s)		Adverse Event and Side Effect
Secondary Outcome(s)		1. Progression-free survival (PFS) 2. PFS at 3 months 3. Objective response rate (ORR: CR + PR) 4. Disease control rate (DCR: CR + PR + SD) 5. Response duration (RD) 6. Overall survival (OS)

Primary Sponsor	J-Pharma Co., Ltd.

Name of Certified Review Board	Institutional Review Board of Osaka University Hospital
Address	2-15 Yamadaoka, Suita-shi, Osaka, Osaka
Telephone	+81-6-6210-8290
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 30, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none