Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-20 @ 3:39 AM
Study NCT ID:
NCT02705469
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For dose escalation only: Incidence of dose-limiting toxicities (DLT)', 'timeFrame': 'Cycle 1 (Day 1 thru Day 28)', 'description': 'A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).'}, {'measure': 'For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694', 'timeFrame': 'Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose', 'description': 'AUC is defined as the area under the curve (plasma concentration of drug over time).'}, {'measure': 'Measure the PK parameter: Cmax of ZEN003694', 'timeFrame': 'Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose', 'description': 'Cmax is defined as maximum or peak plasma concentration of drug.'}, {'measure': 'Measure the PK parameter: Cmin of ZEN003694', 'timeFrame': 'Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose', 'description': 'Cmin is defined as minimum or trough plasma concentration of drug.'}, {'measure': 'Measure the PK parameter: Tmax of ZEN003694', 'timeFrame': 'Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose', 'description': 'Tmax is defined as the time from dosing to the maximum plasma concentration.'}, {'measure': 'Measure the PK parameter: t1/2 of ZEN003694', 'timeFrame': 'Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose', 'description': 't/12 is defined as the half-life of drug.'}, {'measure': 'Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria', 'timeFrame': 'From screening up to 24 months'}, {'measure': 'Evaluate radiographic response rate by PCWG2 criteria', 'timeFrame': 'From screening up to 24 months'}, {'measure': 'Evaluate median progression-free survival by PCWG2 criteria', 'timeFrame': 'From screening up to 24 months'}, {'measure': 'Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only', 'timeFrame': 'From screening up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic Castration-Resistant Prostate Cancer (mCRPC)', 'Phase 1', 'Prostate Cancer', 'Pharmacokinetics (PK)', 'ZEN003694', 'ZEN-3694', 'Metastatic Castrate-Resistant Prostate Cancer', 'BET inhibitor (BETi)', 'Bromodomain', 'Pharmacodynamics (PD)', 'Epigenetics'], 'conditions': ['Metastatic Castration-Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males age ≥ 18 years\n2. Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening\n3. Serum testosterone \\< 50 ng/dL determined within 4 weeks of first administration of study drug\n4. Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Adequate laboratory parameters \\[absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters\\] at screening\n\nExclusion Criteria:\n\n1. Any history of brain metastases or prior seizure or conditions predisposing to seizure activity\n2. Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)\n3. Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug\n4. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry\n5. Radiation therapy within 2 weeks of first administration of study drug\n6. Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)\n7. Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.'}, 'identificationModule': {'nctId': 'NCT02705469', 'briefTitle': 'A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zenith Epigenetics'}, 'officialTitle': 'A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'ZEN003694-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation and Dose Confirmation - ZEN003694 Single Agent', 'description': 'ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients.', 'interventionNames': ['Drug: ZEN003694']}], 'interventions': [{'name': 'ZEN003694', 'type': 'DRUG', 'armGroupLabels': ['Dose Escalation and Dose Confirmation - ZEN003694 Single Agent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zenith Epigenetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}