Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03484520
Status:
TERMINATED
Last Update Posted:
2022-12-30
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C553669', 'term': 'dinaciclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03123029', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tmax of Venetoclax', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Time to maximum plasma concentration (Tmax) of venetoclax.'}, {'measure': 'Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax', 'timeFrame': 'Minimum first cycle of dosing (21 days)', 'description': 'Tthe RPTD of co-administered venetoclax and dinaciclib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.'}, {'measure': 'Cmax of Venetoclax', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Maximum observed plasma concentration (Cmax) for Venetoclax.'}, {'measure': 'AUCt of Venetoclax', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)'}, {'measure': 'AUC0-24 Post-dose of Venetoclax', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.'}, {'measure': 'Cmax of Dinaciclib', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Maximum plasma concentration (Cmax) of dinaciclib.'}, {'measure': 'Half-life (t1/2) of Dinaciclib', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Half-life (t1/2) of dinaciclib.'}, {'measure': 'AUCt Post-dose of Dinaciclib', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.'}, {'measure': 'AUC0-∞ of Dinaciclib', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib.'}, {'measure': 'Clearance of Dinaciclib', 'timeFrame': 'Approximately 29 days after first dose of study drug', 'description': 'Clearance (CL) of dinaciclib.'}], 'secondaryOutcomes': [{'measure': 'Complete Response (CR) Rate', 'timeFrame': 'Up to approximately 18 months', 'description': 'CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.'}, {'measure': 'Composite CR Rate (CR + CRi)', 'timeFrame': 'Up to approximately 18 months', 'description': 'Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 18 months', 'description': 'ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response \\[PR\\]) based on IWG criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib'], 'conditions': ['Cancer - Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.\n\nExclusion Criteria:\n\n* Known central nervous system leukemia\n* Severe chronic obstructive pulmonary disease (COPD) with hypoxemia\n* History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.\n* Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.\n* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.\n* Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.\n* History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.'}, 'identificationModule': {'nctId': 'NCT03484520', 'briefTitle': 'A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'M16-183'}, 'secondaryIdInfos': [{'id': '2017-003213-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax + Dinaciclib', 'description': 'Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Dinaciclib']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['ABT-199', 'GDC-0199'], 'description': 'tablet, oral', 'armGroupLabels': ['Venetoclax + Dinaciclib']}, {'name': 'Dinaciclib', 'type': 'DRUG', 'otherNames': ['MK-7965', 'SCH-727965'], 'description': 'intravenous', 'armGroupLabels': ['Venetoclax + Dinaciclib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas /ID# 200016', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicin /ID# 200015', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University ofChicago /ID# 200017', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201-1544', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine /ID# 204015', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27157-0001', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center /ID# 200288', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University /ID# 200668', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center /ID# 205215', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold coast University Hospital /ID# 202759', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital /ID# 202763', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre /ID# 202762', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal /ID# 201729', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37711', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca /ID# 201728', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politecnico La Fe /ID# 202318', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}