UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017092 |
|---|---|
| Receipt number | R000019824 |
| Scientific Title | Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 in patients with recurrence of castration resistant prostate cancer |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2017/10/18 18:10:38 |
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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 recurrence of castration resistant prostate cancer
Acronym
Phase 1 study of GEN0101 in patients with recurrence of CRPC
Scientific Title
Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 in patients with recurrence of castration resistant prostate cancer
Scientific Title:Acronym
Phase 1 study of GEN0101 in patients with recurrence of CRPC
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary endpoint: To determine the recommended dosage for the phase 2 study through the assessment of DLT(Dose Limiting Toxicity)
Secondary endpoint: 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 shrinkage
- RECIST
- Tumor marker (PSA: Prostate Specific Antigen, NSE: Neuron-specific enolase, CEA: Carcinoembryonic Antigen, CA19-9: Carbohydrate Antigen19-9)
- histological evaluation
2) Induction of antitumor immunity
- NK cell activity
- IL-6
- IFN-gamma
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
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 tumor as confirmed by histology or cytology.
4) Have a diagnosis of recurrence of castration resistant prostate cancer patient and meet below the following condition
- Inapplicable to the standard treatment, ineffective through the criteria of the Prostate Cancer Clinical Trials Working Group (PCWG2) or refuse the standard treatment
- More than 3 weeks between the end date of the standard treatment and the registration date when the standard treatment has been ineffective
5) Serum PSA <100 ng/mL at the screening visit
6) Expected survival period is more than 8 weeks after planned start date of investigational product
7) ECOG Performance Status 0 or 1
8) Have an injectable intraprostatic lesion confirmed by histologic examination
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 within 3 weeks before planned registration date or received radiotherapy or immunotherapy within 6 weeks before planned registration date
/However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody are not included in the systemic chemotherapy.
5) Received another investigational product within 4 weeks before the informed concent
6) Had a history of malignancy other than prostate cancer, except for the relapse-free and metastatis-free for more than 5 years after the last treatment at the registration
7) Have an active autoimmune disease
8)Receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
9) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
10) 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
11) Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit
12) 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 | Norio Nonomura |
Organization
Osaka University Hospital
Division name
Department of Urology
Zip code
Address
2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3531
nono@uro.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 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
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
ISHIHARA SANGYO KAISHA,LTD.
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
大阪大学医学部附属病院（大阪府） Osaka University Hospital（Osaka）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 27 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 26 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019824
