Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 3:11 PM
Study NCT ID:
NCT02722135
Status:
WITHDRAWN
Last Update Posted:
2017-01-27
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'France', 'Germany', 'Italy', 'Netherlands']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541363', 'term': 'BI 6727'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the maximal tolerated dose of volasertib or the recommended volasertib dose for further studies in combination with standard salvage therapy in paediatric patients with AML after failure of the front-line intensive chemotherapy regimen', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Anti-leukaemic activity of volasertib in combination with standard salvage therapy', 'timeFrame': '8 weeks'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'up to 5 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of patients with clinically relevant lab value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as adverse events (Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher)', 'timeFrame': '8 weeks'}, {'measure': 'Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. Adverse Events)', 'timeFrame': '8 weeks'}, {'measure': 'Predose concentration of volasertib before administration of second dose', 'timeFrame': '8 weeks'}, {'measure': 'Area under the concentration-time curve of volasertib', 'timeFrame': '8 weeks'}, {'measure': 'Terminal half-life of volasertib in plasma', 'timeFrame': '8 weeks'}, {'measure': 'Maximum concentration of volasertib', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': 'This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients 3 months to \\<18 years of age at the time of informed consent\n* Patients with AML after failure of the front-line intensive AML therapy\n* Lansky score at screening \\>=50 for patients from 3 months to \\<12 years\n* Karnofsky score at screening \\>=50 for patients from 12 to \\<18 years\n* Use of highly effective methods of birth-control, if sexually active\n* Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group\n\nExclusion criteria:\n\n* Down syndrome\n* Acute promyelocytic leukaemia and treatment-related AML\n* QTc prolongation\n* LVSF \\<30%\n* Cardiac disease and/or dysfunction\n* Active uncontrolled infection\n* HIV infection, acute or chronic hepatitis\n* Inadequate lab parameters\n* Impaired renal function\n* Pregnancy or nursing\n* Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02722135', 'briefTitle': 'A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Open-label, Dose-escalating Trial to Evaluate the Tolerability, Toxicity, Safety, Pharmacokinetics, Pharmacodynamics and Activity of Volasertib Added to the Standard Intensive Salvage Chemotherapy Regimen With Liposomal Daunorubicine, Fludarabine and Cytarabine (DNX-FLA) Followed by Fludarabine and Cytarabine (FLA) in Children From 3 Months to Less Than 18 Years of Age With Acute Myeloid Leukaemia After Failure of the Front-line Therapy', 'orgStudyIdInfo': {'id': '1230.28'}, 'secondaryIdInfos': [{'id': '2015-004625-14', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volasertib', 'interventionNames': ['Drug: Volasertib']}], 'interventions': [{'name': 'Volasertib', 'type': 'DRUG', 'armGroupLabels': ['Volasertib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}