Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-08 @ 2:33 PM
Study NCT ID:
NCT03333005
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0', 'timeFrame': 'One to forty-four days'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'One to forty-four days'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'One to forty-four days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia.\n\nA total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.\n\nAll patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis.\n\nAPX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Provision of written consent\n* Ages 18-75 inclusive, male or female\n* Diagnosis of Acute Myeloid Leukemia\n* Patients entering first induction treatment chemotherapy\n* Expected to be neutropenic (\\<500 ANC/ul) for \\>/= 10 days\n\nKey Exclusion Criteria:\n\n* Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months\n* Current fever (\\> 38 degrees Celsius)\n* Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine'}, 'identificationModule': {'nctId': 'NCT03333005', 'briefTitle': 'Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia', 'orgStudyIdInfo': {'id': 'APX001-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APX001 with Standard of Care Anti-fungal agent', 'interventionNames': ['Drug: APX001 with Standard of Care anti-fungal agent']}], 'interventions': [{'name': 'APX001 with Standard of Care anti-fungal agent', 'type': 'DRUG', 'description': 'safety assessment', 'armGroupLabels': ['APX001 with Standard of Care Anti-fungal agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University of Cologne, Center for Integrated Oncology (CIO)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg, University of Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'University of Munich, Grosshadern Campus', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Marc Engelhardt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Basilea Pharmaceutica International Ltd, Allschwil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basilea Pharmaceutica', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Clinical Trials Centre Cologne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}