Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 9:06 PM
Study NCT ID:
NCT01784757
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2013-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC) of ODM-201', 'timeFrame': '0-48 hrs', 'description': 'The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.'}, {'measure': 'Cmax of ODM-201', 'timeFrame': '0-48 hrs', 'description': 'The plasma peak concentration.'}], 'secondaryOutcomes': [{'measure': 'tmax of ODM-201', 'timeFrame': '0-48 hrs', 'description': 'The time to reach peak concentration.'}, {'measure': 'Terminal elimination rate constant of ODM-201', 'timeFrame': '0-48 hrs', 'description': 'The terminal elimination rate constant from log-linear portion of a concentration-time curve.'}, {'measure': 'Terminal elimination half-life of ODM-201', 'timeFrame': '0-48 hrs', 'description': 'The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '28753851', 'type': 'DERIVED', 'citation': 'Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent (IC) obtained.\n* Histologically confirmed adenocarcinoma of prostate\n* Progressive metastatic disease\n* Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy\n* Adequate bone marrow, hepatic and renal function\n* Able to swallow the ODM-201 whole as a capsule or tablet.\n\nExclusion Criteria:\n\n* Previous chemotherapy for prostate cancer.\n* Known metastases in the brain.\n* History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.\n* Known gastrointestinal condition that can significantly affect the absorption of the study treatment.'}, 'identificationModule': {'nctId': 'NCT01784757', 'acronym': 'ARAFOR', 'briefTitle': 'Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': '3104003'}, 'secondaryIdInfos': [{'id': '2012-002279-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ODM-201 Tablet A', 'description': 'ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.', 'interventionNames': ['Drug: ODM-201 Tablet A', 'Drug: ODM-201 capsule formulation']}, {'type': 'EXPERIMENTAL', 'label': 'ODM-201 Tablet B', 'description': 'ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.', 'interventionNames': ['Drug: ODM-201 Tablet B', 'Drug: ODM-201 capsule formulation']}], 'interventions': [{'name': 'ODM-201 Tablet A', 'type': 'DRUG', 'description': 'Tablet A formulation of ODM-201', 'armGroupLabels': ['ODM-201 Tablet A']}, {'name': 'ODM-201 Tablet B', 'type': 'DRUG', 'description': 'Tablet B formulation of ODM-201', 'armGroupLabels': ['ODM-201 Tablet B']}, {'name': 'ODM-201 capsule formulation', 'type': 'DRUG', 'description': 'Capsule formulation of ODM-201', 'armGroupLabels': ['ODM-201 Tablet A', 'ODM-201 Tablet B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riga', 'country': 'Latvia', 'facility': 'P. Stradina Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}], 'overallOfficials': [{'name': 'Karim Fizazi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Gustave Roussy, University of Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}