UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026892 |
|---|---|
| Receipt number | R000030850 |
| Scientific Title | Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003). |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2023/06/01 16:15:08 |
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Basic information
Public title
Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003).
Acronym
Clinical study with subsequent administration of GEN0101 after the Phase 1 study of chemotherapy-resistant malignant pleural mesothelioma (MMCT01)
Scientific Title
Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003).
Scientific Title:Acronym
Clinical study with subsequent administration of GEN0101 after the Phase 1 study of chemotherapy-resistant malignant pleural mesothelioma (MMCT01)
Region
| Japan |
Condition
Condition
Chemotherapy-resistant Malignant Pleural Mesothelioma
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary endo-point:
to evaluate safety or tolerance of continuous administration of GEN0101 in patients with previously participated in GEN0101-JM003 clinical trial
Secondary endo-point:
to evaluate efficacy of continuous administration of GEN0101 in patients with previously participated in GEN0101-JM003 clinical trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety/Tolerance
Key secondary outcomes
Tumor marker (SMRP)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GEN0101 will be administered to the patients four times per two weeks subcutaneously, and then washed out for two weeks. This one cycle will be repeated 3 times. GEN0101 will be given at a dose of 60,000mNAU for each injection. If the senior PI could confirm safety and efficacy (upper SD score), the same 3 cycles would be continued.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients previously participated and completed GEN0101-JM003 clinical trial.
2) Patients providing a written informed consent by voluntary agreement.
3) Age 20 =< and =<90 years old at the time of informed consent
4) SpO2>=93%
5) Expected survival period is more than 12weeks after planned start date of investigational product
6) ECOG Performance Status 0 or 1
7) The marrow function, liver function and the kidney function must be kept as follows clinical tests within 3weeks before planned registration date or at the screening visit.
(1) leukocyte >= 3,000/mcL
(2) neutrophil >=1,500/mcL
(3) platelet >=75,000/mcL
(4) hemoglobin >=8.0 g/dL.
(5) AST =<100 IU/L
(6) ALT =<100 IU/L
(7) total bilirubin =<2.5 mg/dL
(8) serum creatinine =<2.5 mg/dL
Key exclusion criteria
1) Positive result of the prick test of GEN0101
2) Have serious complications such as uncontrolled active infection
3) Had a history of malignancy other than Malignant Pleural Mesothelioma
4) Have a interstitial pneumonia and pulmonary fibrosis required to treat
6) Have an active autoimmune disease
7) Receiving systemic administration of glucocorticosteroid which restrains immunity response.
8) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
9) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit
10) Women who is pregnant or lactating, except for the woman who discontinue to lactate (from the day of a written informed consent to the day after 30days of discontinue the administration)
In the case of women, to conduct beta-HCG tests to confirm the presence or absence of pregnancy.
11) Inappropriate to be enrolled in this study judged by the investigators
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Meinoshin |
| Middle name | |
| Last name | Okumura |
Organization
Osaka University Hospital
Division name
Center for respiratory
Zip code
565-0871
Address
2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3152
meinosin@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Sakura |
Organization
Osaka University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6210-8289
Homepage URL
Tg4c_1211@hp-mctr.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital, Center for respiratory
Institute
Department
Personal name
Funding Source
Organization
ISHIHARA SANGYO KAISHA,LTD
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
GenomIdea,Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-15, Yamada-oka Suita, Osaka, JAPAN
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030850
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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