UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019345 |
|---|---|
| Receipt number | R000022270 |
| Scientific Title | Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients with Chemotheapy-resistant Malignant Pleural Mesothelioma (Phase I). |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2015/10/14 15:41:01 |
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Basic information
Public title
Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients with Chemotheapy-resistant Malignant Pleural Mesothelioma (Phase I).
Acronym
Phase 1 study of GeN0101 in patients suffering from Chemotheapy-resistant Malignant Pleural Mesothelioma
Scientific Title
Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients with Chemotheapy-resistant Malignant Pleural Mesothelioma (Phase I).
Scientific Title:Acronym
Phase 1 study of GeN0101 in patients suffering from Chemotheapy-resistant Malignant Pleural Mesothelioma
Region
| Japan |
Condition
Condition
Chemotheapy-resistant Malignant Pleural Mesothelioma
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary endopoint:To determine the recommended dosage foe the phase 2 study through the assessment of DLT(Dose Limiting Toxicity)
Secondary endopoint: to evaluate the preliminary efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Assessment of DLT
Key secondary outcomes
1)Effect of tumor shirinkage
- RECIST
- Tumor marker (SMRP, CYFRA)
2)Induction of antitumor immunity
- NK cell
- IL-6
- IFN-gammma
3)Blood concentration of GEN0101/HVJ-E
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 four times per two weeks and then washed out for two weeks. This one cycle will be repeated twice. GEN0101 will be given at a dose of 30,000mNAU for each injection. If dose-escalation is permitted by independent data monitoring committee, another cohort will be given at a dose of 60,000mNAU for each injection.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients providing a written informed consent by voluntary agreement.
2) Age 20 =< and =<85 years old at the time of informed consent
3) Have a diagnosis of malignant pleural mesothelioma as confirmed by histology
4) Patinets suffering from chemoresistant malignant pleural mesothelioma, or patients without consecutive chemotherapy.
- More than 6 week between the end date of the Chemotherapy and the registration date when the Chemotherapy has been ineffective
5) PaO2 >=70 mmHg and SpO2>=93%
6) Expected survival period is more than 8 weeks after planned start date of investigational product
7) ECOG Performance Status 0 or 1
8) Patients with lesions which can be detected by diagnostic imaging such as MRI or CT scan prior to treatment, and which can be administered with GEN0101/HVJE
9) The marrow function, liver function and the kidney function must be kept as follows 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) Have multiple brain metastases
2) Positive result of the prick test of GEN0101
3) Have serious complications such as uncontrolled active infection
4) Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before planned registration date
5) Received another investigational product within 4 weeks before the informed concent
6) Had a history of othr malignancy, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
7) Have a interstitial pneumonia or fibrosing disease of the lung that need treatment
8) Have an active autoimmune disease
9)Receiving systemic administration of glucocorticosteroid which restrains immunity response.
10) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
11) 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
12) Pregnant or lactating women, 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 womane, to conduct beta-HCG tests to confirm the presenceor absence of pregnancy
13) Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit
14) Inappropriate to be enrolled in this study judged by the investigators
Target sample size
12
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
meinosin@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Saito |
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
saitokt@dmi.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital, Center for respiratory
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
| 2015 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 15 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2015 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022270
