Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-22 @ 2:24 PM
Study NCT ID:
NCT02906605
Status:
WITHDRAWN
Last Update Posted:
2016-11-22
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064129', 'term': 'Prostatic Neoplasms, Castration-Resistant'}], 'ancestors': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572045', 'term': 'apalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study start delayed due to pending collection and analysis of additional phase 1 data.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-15', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Prostate-specific Antigen (PSA) Progression', 'timeFrame': 'approximately 2 years', 'description': 'Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).'}], 'secondaryOutcomes': [{'measure': 'PSA Doubling Time (PSADT)', 'timeFrame': 'approximately 2 years', 'description': 'The PSADT will be determined using the method as recommended by PCWG3 criteria.'}, {'measure': 'Radiographic Progression-free Survival', 'timeFrame': 'approximately 2 years', 'description': 'Radiographic progression-free survival, is defined as the time from the date of randomization to the date of radiographic progression or death, whichever occurs first.'}, {'measure': 'Time to Unequivocal Clinical Progression', 'timeFrame': 'approximately 2 years', 'description': 'Time to unequivocal clinical progression defined as the time from the date of randomization to the date of unequivocal clinical progression as evaluated by the investigator.'}, {'measure': 'Overall Survival', 'timeFrame': 'approximately 2 years', 'description': 'Overall survival defined as time from the date of randomization to death from any cause.'}, {'measure': 'Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability', 'timeFrame': 'approximately 2 years', 'description': 'Comparison of the AE profiles of the two treatment groups.'}, {'measure': 'Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva', 'timeFrame': 'approximately 2 years', 'description': 'Blood culture samples will be collected after the mandatory prophylactic antibiotic therapy. Bacterial shedding will be evaluated from cultured samples of feces by stool or rectal swab, urine, and sputum.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms, Castration-Resistant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adenocarcinoma of the prostate\n* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans\n* Surgically or medically castrated, with testosterone levels of less than (\\<)50 nanogram per deciliter (ng/dL)\n* Castration-resistant prostate cancer documented by time to prostate-specific antigen (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR radiographic progression of soft tissues OR radiographic progression of bone according to PCWG3\n\nExclusion Criteria:\n\n* Predominately small cell or neuroendocrine carcinoma of the prostate\n* Known brain metastases (even if treated) or untreated epidural spread\n* Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer\n* Treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (\\>=)28 days prior to randomization'}, 'identificationModule': {'nctId': 'NCT02906605', 'briefTitle': 'A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-label, Randomized, Phase 2 Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'CR108224'}, 'secondaryIdInfos': [{'id': '64041809PCR2002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2016-001917-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JNJ-809 plus Apalutamide (Group A)', 'description': 'JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.', 'interventionNames': ['Drug: JNJ-809', 'Drug: Apalutamide']}, {'type': 'EXPERIMENTAL', 'label': 'Apalutamide (Group B)', 'description': 'Apalutamide 240 mg orally daily.', 'interventionNames': ['Drug: Apalutamide']}], 'interventions': [{'name': 'JNJ-809', 'type': 'DRUG', 'description': 'JNJ-809 (1\\*10\\^9) colony forming units (CFU) given as an infusion.', 'armGroupLabels': ['JNJ-809 plus Apalutamide (Group A)']}, {'name': 'Apalutamide', 'type': 'DRUG', 'description': 'Apalutamide 240 mg orally daily.', 'armGroupLabels': ['Apalutamide (Group B)', 'JNJ-809 plus Apalutamide (Group A)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}