Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-04 @ 11:40 PM
Study NCT ID:
NCT03074032
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-08', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)', 'timeFrame': '4 weeks and during the study up to 76 weeks', 'description': 'Incidence rate and severity of adverse events, changes in laboratory tests'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '28 days', 'description': 'PK analysis of ONC1-0013B after single and multiple dosage'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '28 days', 'description': 'PK analysis of ONC1-0013B after single and multiple dosage'}, {'measure': 'Elimination half-life (T1/2)', 'timeFrame': '28 days', 'description': 'PK analysis of ONC1-0013B after single and multiple dosage'}, {'measure': 'Time-to-peak concentration (tmax)', 'timeFrame': '28 days', 'description': 'PK analysis of ONC1-0013B after single and multiple dosage'}, {'measure': 'Steady-State Concentration (Css)', 'timeFrame': '28 days', 'description': 'PK analysis of ONC1-0013B after single and multiple dosage'}, {'measure': 'Tumor response', 'timeFrame': '12 weeks and during the study up to 76 weeks', 'description': 'RECIST 1.1 criteria and the change of the PSA level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration-Resistant Prostate Cancer (mCRPC)']}, 'descriptionModule': {'briefSummary': 'This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men aged 18 years and older.\n2. Histologically confirmed diagnosis of prostate cancer\n3. Castrate level of testosterone in blood serum \\< 1,7 nmol/l or \\< 50 ng/dl\n4. PSA level at screening \\> 2 ng/ml\n5. Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.\n6. The patient's ECOG performance status of 0 - 2\n7. Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC\n8. The expected survival time of not less than 12 weeks\n\nExclusion Criteria:\n\n1. Prior anticancer therapy:\n\n * Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)\n * Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening\n * Exposure to bisphosphonates is allowed only if the treatment started prior to screening\n2. Clinically significant cardiovascular system diseases:\n3. Clinically significant central nervous system diseases:\n4. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)\n5. Prior or concomitant therapy:\n\n * Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening\n * Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening\n * Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment"}, 'identificationModule': {'nctId': 'NCT03074032', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avionco LLC'}, 'officialTitle': 'Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'orgStudyIdInfo': {'id': 'ONC-ONC10013B-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONC1-0013B 40 mg', 'description': 'ONC1-0013B 40 mg per os daily', 'interventionNames': ['Drug: ONC1-0013B']}, {'type': 'EXPERIMENTAL', 'label': 'ONC1-0013B 80 mg', 'description': 'ONC1-0013B 80 mg per os daily', 'interventionNames': ['Drug: ONC1-0013B']}, {'type': 'EXPERIMENTAL', 'label': 'ONC1-0013B 160 mg', 'description': 'ONC1-0013B 160 mg per os daily', 'interventionNames': ['Drug: ONC1-0013B']}, {'type': 'EXPERIMENTAL', 'label': 'ONC1-0013B 320 mg', 'description': 'ONC1-0013B 320 mg per os daily', 'interventionNames': ['Drug: ONC1-0013B']}], 'interventions': [{'name': 'ONC1-0013B', 'type': 'DRUG', 'description': 'ONC1-0013B per os daily', 'armGroupLabels': ['ONC1-0013B 160 mg', 'ONC1-0013B 320 mg', 'ONC1-0013B 40 mg', 'ONC1-0013B 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105426', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Institute of Urology and Interventional Radiology n.a. N.A. Lopatkin (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '249036', 'city': 'Obninsk', 'country': 'Russia', 'facility': 'Medical Radiological Research Center n.a. A.F. Tsyb (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avionco LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}