Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03478904
Status:
TERMINATED
Last Update Posted:
2021-05-10
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D055534', 'term': 'Bulbo-Spinal Atrophy, X-Linked'}], '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'}, {'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'figgw@mail.nih.gov', 'phone': '240-760-6179', 'title': 'William D. Figg, Pharm.D.', 'organization': 'National Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Date treatment consent signed to date off study, approximately 7 months and 24 days.', 'description': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)', 'eventGroups': [{'id': 'EG000', 'title': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Curve (AUC) for the First Period of Administration and Second Period of Administration of Two Formulations of Enzalutamide and the Active Metabolite of Enzalutamide Following a Single 160mg Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '160mg Enzalutamide Liquid', 'description': 'Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)'}, {'id': 'OG001', 'title': '4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}], 'classes': [{'title': 'Day 42 - Enzalutamide', 'categories': [{'measurements': [{'value': '329.14', 'groupId': 'OG000'}, {'value': '295.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 - N-Desmethyl Enzalutamide', 'categories': [{'measurements': [{'value': '617.52', 'groupId': 'OG000'}, {'value': '529.18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'AUC is the cumulative drug exposure (drug concentration \\* time) for this single dose over a 42-day sampling period. Participants were randomized to receive Enzalutamide gel capsule 4x40mg (Treatment A) followed by enzalutamide liquid 160mg orally (Treatment B), or Enzalutamide liquid 160mg orally (Treatment B) followed by enzalutamide gel capsule 4x40mg (Treatment A). The difference in the AUCs were calculated following a published non-parametric and noncompartmental approach. A difference of less than 20% difference in the AUC for the test version vs. the standard formulation would permit the two formulations to be considered bioequivalent."\n\n\\*The calculated AUC values for N-Desmethyl Enzalutamide of the "4x40mg Enzalutamide Capsule" formulation was influenced by detectable concentrations of N-Desmethyl Enzalutamide (an active metabolite of Enzalutamide) following the 42 Day washout period between the two doses.', 'unitOfMeasure': 'AUC ug*h/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B).'}, {'type': 'SECONDARY', 'title': 'Number of Episodes of Grades 1-5 Nausea and Vomiting on 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Gel Capsule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Grade 1', 'description': 'Grade 1 is mild.'}, {'id': 'OG001', 'title': 'Grade 2', 'description': 'Grade 2 is moderate.'}, {'id': 'OG002', 'title': 'Grade 3', 'description': 'Grade 3 is severe or medically significant but not life-threatening.'}, {'id': 'OG003', 'title': 'Grade 4', 'description': 'Grade 4 is life-threatening consequences.'}, {'id': 'OG004', 'title': 'Grade 5', 'description': 'Grade 5 is death related to adverse event.'}], 'classes': [{'title': 'Nausea Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Nausea Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Nausea Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Nausea Day 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vomiting Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vomiting Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vomiting Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Vomiting Day 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 3, 8, and 42', 'description': 'Nausea and vomiting adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life threatening consequences, and Grade 5 is death related to adverse event.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B); Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg); Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Date treatment consent signed to date off study, approximately 7 months and 24 days.', 'description': 'Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B); Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg); Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Grade 3 Vomiting Compared Between Two Formulations of Enzalutamide at Each Time Point Using Fishers Exact Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}], 'timeFrame': 'Day 1, 3, 8, and 42', 'description': 'Proportion of participants with Grade 3 vomiting assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., compared between two formulations of enzalutamide at each time point using Fishers exact test.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done. Planned comparisons between the two formulations of enzalutamide at each time point using Fishers exact test were not conducted due to limited study accrual (n=1).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.2', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)\n\nEnzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)\n\nEnzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-11', 'size': 589546, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-15T12:48', 'hasProtocol': True}, {'date': '2020-04-15', 'size': 173047, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-15T12:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study drug is now commercially available in tablet format', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2018-03-21', 'resultsFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2018-03-24', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-12', 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC) for the First Period of Administration and Second Period of Administration of Two Formulations of Enzalutamide and the Active Metabolite of Enzalutamide Following a Single 160mg Dose', 'timeFrame': 'Day 42', 'description': 'AUC is the cumulative drug exposure (drug concentration \\* time) for this single dose over a 42-day sampling period. Participants were randomized to receive Enzalutamide gel capsule 4x40mg (Treatment A) followed by enzalutamide liquid 160mg orally (Treatment B), or Enzalutamide liquid 160mg orally (Treatment B) followed by enzalutamide gel capsule 4x40mg (Treatment A). The difference in the AUCs were calculated following a published non-parametric and noncompartmental approach. A difference of less than 20% difference in the AUC for the test version vs. the standard formulation would permit the two formulations to be considered bioequivalent."\n\n\\*The calculated AUC values for N-Desmethyl Enzalutamide of the "4x40mg Enzalutamide Capsule" formulation was influenced by detectable concentrations of N-Desmethyl Enzalutamide (an active metabolite of Enzalutamide) following the 42 Day washout period between the two doses.'}], 'secondaryOutcomes': [{'measure': 'Number of Episodes of Grades 1-5 Nausea and Vomiting on 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Gel Capsule', 'timeFrame': 'Day 1, 3, 8, and 42', 'description': 'Nausea and vomiting adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life threatening consequences, and Grade 5 is death related to adverse event.'}, {'measure': 'Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0', 'timeFrame': 'Date treatment consent signed to date off study, approximately 7 months and 24 days.', 'description': 'Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.'}, {'measure': 'Proportion of Participants With Grade 3 Vomiting Compared Between Two Formulations of Enzalutamide at Each Time Point Using Fishers Exact Test', 'timeFrame': 'Day 1, 3, 8, and 42', 'description': 'Proportion of participants with Grade 3 vomiting assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., compared between two formulations of enzalutamide at each time point using Fishers exact test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Castration Resistant Prostate Cancer', 'Androgen Receptor'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34333820', 'type': 'DERIVED', 'citation': 'Cordes LM, Schmidt KT, Peer CJ, Chau CH, Redmond E, Francis D, Karzai F, Madan RA, Figg WD. Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single-Dose Administration Under Fasting Conditions in Prostate Cancer. Oncologist. 2021 Sep;26(9):729-e1493. doi: 10.1002/onco.13919. Epub 2021 Aug 14.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2018-C-0070.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nEnzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole.\n\nObjectives:\n\nTo compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer.\n\nEligibility:\n\nMen at least 18 years old with prostate cancer\n\nDesign:\n\nParticipants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed.\n\nDuring the study, participants will repeat screening tests and have urine tests.\n\nParticipants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).\n\nParticipants will be counseled about birth control.\n\nThe study will have 2 periods with a minimum 42 day break in between.\n\nOn Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form.\n\nParticipants will have blood drawn on Day 3, Day 8, and Day 42.', 'detailedDescription': 'Background:\n\n* Enzalutamide is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)\n* The marketed (reference) formulation of enzalutamide is a liquid-filled, soft gelatin capsule containing 40 mg enzalutamide dissolved in Labrasol; four such capsules are required to deliver a 160 mg dose\n* The four-capsule regimen is inconvenient because of the number of capsules that must be taken, particularly in light of the fact that cancer patients usually have to take multiple drugs.\n* Additionally, some patients may not be able to swallow pills; therefore, alternate methods of oral administration are necessary\n\nObjectives:\n\n-To evaluate the bioequivalence, safety, and tolerability of two oral formulations of enzalutamide following a single 160 mg dose in male subjects with prostate cancer under fasting conditions.\n\nEligibility:\n\n-Male subjects with prostate cancer\n\nDesign:\n\n* Comparative, randomized, open-label, single-dose, 2-way crossover bioavailability, safety and tolerability study\n* Subjects will be randomized in Period 1 to one of two sequences: AB or BA. Following a minimum 42-day washout period, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.\n* Treatment A will be the standard capsule (reference) formulation; Treatment B will be the liquid formulation (test product)\n* Blood samples will be collected for pharmacokinetic analysis'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed prostate cancer.\n\nNote: If histopathological documentation is unavailable, a clinical course consistent with prostate cancer is acceptable.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Patients must have adequate organ and marrow function as defined below:\n\n * Hemoglobin greater than or equal to 9 g/dL\n * leukocytes greater than or equal to 3000/mcL\n * absolute neutrophil count greater than or equal to 1500/mcL\n * platelets greater than or equal to 150000/mcL\n * total bilirubin within normal institutional limits\n * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/ alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to X institutional upper limit of normal\n * creatinine within normal institutional limits\n\nOR\n\n--creatinine clearance greater than or equal to 30 mL/min/1.73 m\\^2 for patients with creatinine levels above institutional normal (calculated via Cockcroft-Gault equation)\n\n* Patients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai Stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning enzalutamide).\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willingness to travel to National Institutes of Health (NIH) for follow-up visits.\n* Men age greater than or equal to 18 years of age. Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men\n* The effects of enzalutamide on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout the course of the study and for 3 months after the last dose. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 7 days).\n* Patients must not be on enzalutamide within five half-lives before the first planned dose of the study drug or anticipating to start enzalutamide within the next 3 months of the first planned dose of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study.\n* Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Patients who are taking medications that may alter the metabolism of enzalutamide. This includes the following: strong or moderate cytochrome P450 family 2 subfamily C member 8 (CYP2C8) inhibitors or inducers; strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inhibitors or inducers; or Cytochrome P450 2C9 (CYP2C9), 2C19 or 3A4 substrates with a narrow therapeutic index.\n* History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attach, or any condition that may pre-dispose to seizure (e.g. prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).'}, 'identificationModule': {'nctId': 'NCT03478904', 'briefTitle': 'Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer', 'orgStudyIdInfo': {'id': '180070'}, 'secondaryIdInfos': [{'id': '18-C-0070'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid', 'description': 'Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)', 'interventionNames': ['Drug: Enzalutamide Liquid', 'Drug: Enzalutamide Capsule']}, {'type': 'EXPERIMENTAL', 'label': '160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', 'description': 'Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A)', 'interventionNames': ['Drug: Enzalutamide Liquid', 'Drug: Enzalutamide Capsule']}], 'interventions': [{'name': 'Enzalutamide Liquid', 'type': 'DRUG', 'otherNames': ['ASP-9785'], 'description': 'Enzalutamide liquid formulation given orally (160mg)', 'armGroupLabels': ['160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', '4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid']}, {'name': 'Enzalutamide Capsule', 'type': 'DRUG', 'otherNames': ['ASP-9785'], 'description': 'Enzalutamide gel capsule (4X 40mg)', 'armGroupLabels': ['160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule', '4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'William D Figg, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Figg', 'investigatorAffiliation': 'National Cancer Institute (NCI)'}}}}