Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-29 @ 7:40 PM
Study NCT ID:
NCT02835794
Status:
WITHDRAWN
Last Update Posted:
2017-05-03
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077863', 'term': 'Homoharringtonine'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D006248', 'term': 'Harringtonines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding to support clinical trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants who demonstrate changes in chromosome karyotype and genetic mutations', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'The maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory low- and intermediate-risk MDS.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Hematologic Improvement (HI) as measured by hemoglobin, platelet count and neutrophil count.', 'timeFrame': '12 months'}, {'measure': 'Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria.', 'timeFrame': '12 months'}, {'measure': 'Number of participants who achieve complete remission and how long the response lasts', 'timeFrame': '24 months'}, {'measure': 'Length of time of survival for participants', 'timeFrame': '24 months'}, {'measure': 'Incidences of Grade 3/4 adverse events directly related to the drug combination', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes'], 'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and establish the maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory MDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years;\n* Informed consent;\n* Low- and intermediate-risk MDS that has failed to achieve any hematologic improvement after at least 4 cycles of induction therapy or has relapsed after any duration of any hematologic response. Prior therapy with azanucleosides (i.e., azacitidine, decitabine), biologic therapies (i.e., lenalidomide, rigosertib) and hematopoietic cell transplant are permissible;\n* Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2;\n* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions:\n\n * Must agree to use physician-approved contraceptive methods throughout the study and for three months following the last dose of omacetaxine and\n * Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial;\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving a child for 6 months following the last dose of omacetaxine.\n\nExclusion Criteria:\n\n* Subjects who are eligible for hematopoietic stem cell transplant;\n* History of atrial fibrillation related to azanucleoside therapy in the past;\n* Active, uncontrolled, clinically significant infection;\n* Pregnant and nursing patients are excluded because the effects of omacetaxine on a fetus or nursing child are unknown;\n* Treatment with any anticancer therapy (standard or investigational) within the previous 14 days prior to the first dose of study drug or less than full recovery from the clinically significant toxic effects of that treatment.'}, 'identificationModule': {'nctId': 'NCT02835794', 'briefTitle': 'A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'A Phase I/II Clinical Trial of Omacetaxine, Azacitidine, and G-CSF for Relapsed and/or Refractory Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': 'IRB201601194'}, 'secondaryIdInfos': [{'id': 'UF-MDS-OAG-101', 'type': 'OTHER', 'domain': 'UF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Omacetaxine - escalating doses subcutaneous twice daily on Days 1-5 and 8-12 Azacitidine 50 mg/m2 subcutaneous/intravenous daily on Days 8-12 G-CSF 5mcg/kg subcutaneous daily on Days 15-19 and 22-26', 'interventionNames': ['Drug: Omacetaxine', 'Drug: Azacitidine', 'Drug: G-CSF']}], 'interventions': [{'name': 'Omacetaxine', 'type': 'DRUG', 'otherNames': ['Synribo'], 'description': 'Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF', 'armGroupLabels': ['Arm 1']}, {'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['Vidaza'], 'description': 'Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF', 'armGroupLabels': ['Arm 1']}, {'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['Neupogen'], 'description': 'Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Shands Cancer Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Maxim N. Norkin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teva Pharmaceutical Industries, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}