Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-28 @ 1:26 PM
Study NCT ID:
NCT03797261
Status:
TERMINATED
Last Update Posted:
2021-12-07
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C000720001', 'term': 'tapotoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Safety', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176', 'timeFrame': 'Up to 28 days after first dose of study drug in a dose-escalation phase', 'description': 'The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years).', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Composite Complete Remission Rate (CRc) for Participants with AML', 'timeFrame': 'Up to approximately 2 years from last subject first dose', 'description': 'CRc rate is defined as CR + CRi (CR with incomplete blood count recovery).'}, {'measure': 'Objective Response Rate (ORR) for Participants with AML', 'timeFrame': 'Up to approximately 2 years from last subject first dose', 'description': 'ORR is defined as the percentage of participants with documented partial response (PR) or better (CR + CRi + partial response \\[PR\\]) based on International Working Group (IWG) criteria for AML'}, {'measure': 'ORR for Participants with NHL', 'timeFrame': 'Up to approximately 2 years from last subject first dose', 'description': 'ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Venetoclax', 'timeFrame': 'Up to approximately 28 days after first dose of study drug', 'description': 'Maximum observed plasma concentration (Cmax) of venetoclax.'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax', 'timeFrame': 'Up to approximately 28 days after first dose of study drug', 'description': 'Time to maximum plasma concentration (Tmax) of Venetoclax.'}, {'measure': 'AUC of Venetoclax', 'timeFrame': 'Up to approximately 28 days after first dose of study drug', 'description': 'Area under the plasma concentration-time curve (AUC) of venetoclax.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of AMG 176', 'timeFrame': 'Up to approximately 16 days after first dose of study drug', 'description': 'Maximum observed plasma concentration (Cmax) of AMG 176'}, {'measure': 'Half-life (t1/2) of AMG 176', 'timeFrame': 'Approximately 16 days after first dose of study drug', 'description': 'Terminal phase elimination half-life (t1/2)'}, {'measure': 'AUC of AMG 176', 'timeFrame': 'Approximately 16 days after first dose of study drug', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) of AMG 176'}, {'measure': 'Clearance (CL) of AMG 176', 'timeFrame': 'Approximately 16 days after first dose of study drug', 'description': 'Clearance (CL) is defined the volume of plasma cleared of the drug per unit time.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', "Non-Hodgkin's Lymphoma", 'Cancer', 'Venetoclax', 'AMG 176', 'diffuse large B-cell lymphoma (DLBCL)'], 'conditions': ['Acute Myeloid Leukemia', "Non-Hodgkin's Lymphoma", 'Diffuse Large B-cell Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).\n\nThis study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adequate kidney, liver and hematology values as described in the protocol.\n* Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.\n* Meets the following disease activity criteria:\n* AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.\n* NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.\n\nExclusion Criteria:\n\n* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.\n* History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.\n* Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.\n* Previous enrollment in a randomized trial including either venetoclax or AMG 176.\n* Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.\n* Active, uncontrolled infection."}, 'identificationModule': {'nctId': 'NCT03797261', 'briefTitle': 'A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'M16-785'}, 'secondaryIdInfos': [{'id': '2018-003314-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax + AMG 176', 'description': 'Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.', 'interventionNames': ['Drug: Venetoclax', 'Drug: AMG 176']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['ABT-199'], 'description': 'tablet, oral', 'armGroupLabels': ['Venetoclax + AMG 176']}, {'name': 'AMG 176', 'type': 'DRUG', 'description': 'solution, intravenous', 'armGroupLabels': ['Venetoclax + AMG 176']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope /ID# 207393', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Cancer Center /ID# 207396', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics /ID# 207459', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ Kansas Med Ctr /ID# 207480', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Duplicate_Dana-Farber Cancer Institute /ID# 207367', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 206995', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016-6402', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center /ID# 207390', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc /Id# 207388', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Ctr /ID# 208482', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle /ID# 211455', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital /ID# 210602', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health /ID# 210350', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitaetsklinikum Frankfurt /ID# 207984', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig /ID# 209824', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 207987', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 207803', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207788', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}