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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026892
Receipt No. 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 2017/05/23

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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
Middle name
Last name Meinoshin Okumura
Organization Osaka University Hospital
Division name Center for respiratory
Zip code
Address 2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6879-3152
Email meinosin@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Lee Chunman
Organization Osaka University Hospital
Division name Medical Center for Translational and Clinical Research
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6210-8289
Homepage URL
Email Tg4c_1211@hp-mctr.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital, Center for respiratory
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 14 Day
Last follow-up date
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
2017 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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