UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030948 |
|---|---|
| Receipt number | R000034417 |
| Scientific Title | Propagermanium monotherapy in patients with relapsed or refractory cancer. |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2019/01/22 16:05:04 |
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Basic information
Public title
Propagermanium monotherapy in patients with relapsed or refractory cancer.
Acronym
PG monotherapy in cancer patients
Scientific Title
Propagermanium monotherapy in patients with relapsed or refractory cancer.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shojiro Kikuchi |
Organization
Hyogo College of Medicine
Division name
Institute for Advanced Medical Sciences
Zip code
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
TEL
0798-45-6229
skikuchi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shojiro Kikuchi |
Organization
Hyogo College of Medicine
Division name
Institute for Advanced Medical Sciences
Zip code
Address
Mukogawa-cho 1-1, Nishinomiya, Hyogo 663-8501
TEL
0798-45-6229
Homepage URL
skikuchi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine, Institute for Advanced Medical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034417
