Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-06 @ 2:12 PM
Study NCT ID:
NCT01902251
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2013-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients
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': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)', 'timeFrame': 'Day1 through Day 56 (12 samples)', 'description': 'Day 56 (fasted) Cmax under steady state conditions of enzalutamide'}, {'measure': 'Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)', 'timeFrame': 'Day1 through Day 56 (12 samples)', 'description': 'Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile of Enzalutamide under fasted and fed conditions', 'timeFrame': 'Day 1, 8, 29, 55, 56 and 57 (38 samples)', 'description': 'Measured by: Cmax, tmax (Time to attain Cmax), AUC0-24h, Ctrough (Trough concentration), PTR (Peak-trough ratio), CLss/F (Apparent clearance at steady state)'}, {'measure': 'Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002', 'timeFrame': 'Day 8, 29, 55, 56 and 57 (26 samples)', 'description': 'Measured by: Ctrough, Cmax, tmax, AUC0-24h, Ctrough (24h after dosing), PTR'}, {'measure': 'Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments', 'timeFrame': 'Day 1 through Day 58'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Prostate cancer', 'Bioavailability', 'Food effect', 'Pharmacokinetics', 'Xtandi', 'Enzalutamide', 'MDV3100'], 'conditions': ['Prostate Cancer', 'Pharmacokinetics of Enzalutamide']}, 'descriptionModule': {'briefSummary': 'A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.\n* Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:\n\n * PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL);\n * Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease\n * Bone disease progression defined by two or more new lesions on bone scan\n\nExclusion Criteria:\n\n* Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.\n* History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).\n* Patients who previously received treatment with Enzalutamide.\n* Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8.\n* Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.'}, 'identificationModule': {'nctId': 'NCT01902251', 'briefTitle': 'Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer', 'orgStudyIdInfo': {'id': '9785-CL-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enzalutamide tablet', 'description': 'Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks', 'interventionNames': ['Drug: Enzalutamide tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enzalutamide capsule', 'description': 'Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks', 'interventionNames': ['Drug: Enzalutamide capsule']}], 'interventions': [{'name': 'Enzalutamide tablet', 'type': 'DRUG', 'otherNames': ['Xtandi', 'MDV3100'], 'description': 'Oral', 'armGroupLabels': ['Enzalutamide tablet']}, {'name': 'Enzalutamide capsule', 'type': 'DRUG', 'otherNames': ['Xtandi', 'MDV3100'], 'description': 'Oral', 'armGroupLabels': ['Enzalutamide capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Anschutz Medical Campus', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Study Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medivation, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}