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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017092
Receipt No. 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

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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
Last 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
Email nono@uro.med.osaka-u.ac.jp

Public contact
1st 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
Email saitokt@dmi.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019824

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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