Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-24 @ 10:44 AM
Study NCT ID:
NCT02680795
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2016-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487081', 'term': 'belinostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma and urine concentrations of belinostat will be measured', 'timeFrame': '26 Weeks', 'description': 'PK will be measured for area under the time-concentration curve (AUC), steady state volume of distribution (Vdss),PK will be measured for total body clearance (CLtot),PK will be measured for fraction excreted unchanged (fe), PK will be measured for renal clearance (CLren), PK will be measured for non-renal clearance (CLnonren), PK will be measured for peak concentration (Cmax),and half-life (t1/2)'}], 'secondaryOutcomes': [{'measure': 'Assess overall incidence of treatment emergent adverse events (TEAEs) using CTCAE version 4.03', 'timeFrame': '26 Weeks', 'description': 'Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1\\*28 genotypes'}, {'measure': 'Assess any adverse events (AEs) (changes in physical exam or laboratory findings related to study medication dosing', 'timeFrame': '26 Weeks', 'description': 'Assess Safety of belinostat in patients with wild type, heterozygous, and homozygousUGT1A1\\*28 genotypes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UGT1A1*28', 'Belinostat', 'beleodaq', 'wild type genotypes', 'heterozygous genotypes', 'homozygous genotypes'], 'conditions': ['Solid Tumors', 'Hematological Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype', 'detailedDescription': 'This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype\n\nEnrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.\n2. Patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.\n3. Patient has adequate hematological and hepatic functions.\n\nExclusion Criteria:\n\n1. Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.\n2. Patient has HBV or HCV\n3. Patient has a known HIV positive diagnosis.\n4. Patient has congestive heart failure Class III/IV\n5. Patient has had previous exposure to belinostat.'}, 'identificationModule': {'nctId': 'NCT02680795', 'briefTitle': 'Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acrotech Biopharma Inc.'}, 'officialTitle': 'Open-label, Nonrandomized, Phase 1 Study Evaluating Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies in Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes', 'orgStudyIdInfo': {'id': 'SPI-BEL-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wild Type UGT1A1', 'description': 'Cohort A: Open for Enrollment Wild Type UGT1A1, Belinostat IV', 'interventionNames': ['Drug: Belinostat IV']}, {'type': 'EXPERIMENTAL', 'label': 'Heterozygous UGT1A1*28', 'description': 'Cohort B: Closed For Enrollment Heterozygous UGT1A1, Belinostat IV', 'interventionNames': ['Drug: Belinostat IV']}, {'type': 'EXPERIMENTAL', 'label': 'Homozygous UGT1A1*28', 'description': 'Cohort C: Open For Enrollment Homozygous UGT1A1, Belinostat IV', 'interventionNames': ['Drug: Belinostat IV']}], 'interventions': [{'name': 'Belinostat IV', 'type': 'DRUG', 'otherNames': ['Beleodaq'], 'description': 'Cohort A:\n\nBelinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.\n\nCohort B:\n\nBelinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.\n\nCohort C:\n\nBelinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.', 'armGroupLabels': ['Heterozygous UGT1A1*28', 'Homozygous UGT1A1*28', 'Wild Type UGT1A1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "John Wayne Cancer Institute @ Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}], 'overallOfficials': [{'name': 'Wasim Khan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acrotech Biopharma Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acrotech Biopharma Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Axis Clinicals Limited', 'class': 'INDUSTRY'}, {'name': 'Axis Clinical Trials', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}