Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-30 @ 12:23 PM
Study NCT ID:
NCT01493869
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2011-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558660', 'term': 'cabozantinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-19', 'studyFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity', 'timeFrame': 'Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22', 'description': 'Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects', 'timeFrame': 'Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal healthy adult subjects', 'Adult subjects with hepatic impairment'], 'conditions': ['Healthy', 'Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight must be ≥50 kg and \\<130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).\n* Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.\n* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.\n* Must have adequate vital sign reads at screening and check-in.\n* Must be able to comply with dietary and fluid restrictions required for the study'}, 'identificationModule': {'nctId': 'NCT01493869', 'briefTitle': 'Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exelixis'}, 'officialTitle': 'A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects', 'orgStudyIdInfo': {'id': 'XL184-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Subjects with normal hepatic function: healthy normal adult subjects', 'interventionNames': ['Drug: cabozantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).', 'interventionNames': ['Drug: cabozantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).', 'interventionNames': ['Drug: cabozantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).', 'interventionNames': ['Drug: cabozantinib']}], 'interventions': [{'name': 'cabozantinib', 'type': 'DRUG', 'otherNames': ['XL184'], 'description': '3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exelixis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}