UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Propagermanium monotherapy in patients with relapsed or refractory cancer.
Title of the study (Brief title)	PG monotherapy in cancer patients
Region	Japan

Condition
Condition	relapsed or refractory cancer.
Classification by specialty	Gastroenterology Hematology and clinical oncology Oral surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and Safety
Basic objectives2	Others
Basic objectives -Others	Immune cell analysis Predictive biomarker exploration
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Adverse effect, Disease control ratio, Progression free survival, Predictive biomarker

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Propagerumanium 30mg day, consecutively for one year
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	relapse or refractory cancer patients
Key exclusion criteria	1) active lesion of the other type of cancer, except of gastric and head/neck cancer 2) Immunotherapy
Target sample size	30

Research contact person
Name of lead principal investigator	Shojiro Kikuchi
Organization	Hyogo College of Medicine
Division name	Institute for Advanced Medical Sciences
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6229
Email	skikuchi@hyo-med.ac.jp

Public contact
Name of contact person	Shojiro Kikuchi
Organization	Hyogo College of Medicine
Division name	Institute for Advanced Medical Sciences
Address	Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6229
Homepage URL
Email	skikuchi@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine, Institute for Advanced Medical Sciences
Institute
Department

Funding Source
Organization	Toray Industries, Inc. Sanwa Kagaku Kenkyusho CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 12 Month 05 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034417