Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT02502994
Status:
UNKNOWN
Last Update Posted:
2015-07-20
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT (Dose Limiting Toxicity)', 'timeFrame': '8 weeks', 'description': 'To determine the appropriate dosing strategy for GEN0101 for castration resistant prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Number of participants with tumor shrinkage according to the RECIST.', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in tumor marker (PSA: Prostate Specific Antigen, NSE: Neuron-specific enolase, CEA: Carcinoembryonic Antigen, and CA19-9: Carbohydrate Antigen19-9) at Cycle 1, Week 4 and at Cycle 2, Week 4.', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in prostate histological evaluation at Cycle2, Week2.', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in induction of antitumor immunity (NK cell activity, IL-6 and IFN-gamma) at Cycle1, Week 2 and Week 4 and at Cycle2, Week 2 and Week 4.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Castration Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer.\n\nThe subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period.\n\nLow dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients providing a written informed consent by voluntary agreement.\n2. Age 20 =\\< and =\\<85 years old at the time of informed consent\n3. Have a diagnosis of malignant tumor as confirmed by histology or cytology.\n4. Have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition\n\n * Inapplicable to the standard treatment, ineffective through the criteria of the Prostate Cancer Clinical Trials Working Group (PCWG2) or refuse the standard treatment\n * More than 6 week between the end date of the standard treatment and the registration date when the standard treatment has been ineffective\n5. Serum PSA \\<100 ng/mL at the screening visit\n6. Expected survival period is more than 8 weeks after planned start date of investigational product\n7. ECOG Performance Status 0 or 1\n8. Have an injectable intraprostatic lesion confirmed by histologic examination\n9. 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\n\nExclusion Criteria:\n\n1. Have multiple brain metastases\n2. Positive result of the prick test of GEN0101\n3. Have serious complications such as uncontrolled active infection\n4. Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody is are not included in the systemic chemotherapy.\n5. Received another investigational medical product within 4 weeks before the informed concent\n6. Had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration\n7. Have an active autoimmune disease\n8. 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).\n9. Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)\n10. 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\n11. Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit\n12. Inappropriate to be enrolled in this study judged by the investigators'}, 'identificationModule': {'nctId': 'NCT02502994', 'briefTitle': 'Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GEN0101-JM002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Single arm of the castration resistant prostate cancer', 'interventionNames': ['Drug: GEN0101']}], 'interventions': [{'name': 'GEN0101', 'type': 'DRUG', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Urology, Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Norio Nonomura, MD', 'role': 'CONTACT', 'email': 'nono@uro.med.osaka-u.ac.jp', 'phone': '+81668793531'}, {'name': 'Katsuhisa Saito', 'role': 'CONTACT', 'email': 'saitokt@dmi.med.osaka-u.ac.jp', 'phone': '+81662108289'}], 'overallOfficials': [{'name': 'Norio Nonomura, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology, Osaka University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norio Nonomura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Norio Nonomura', 'investigatorAffiliation': 'Osaka University'}}}}