Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT02143635
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2014-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654196', 'term': 'siremadlin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'up to 28 days', 'description': 'DLTs in the first cycle of treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events (AEs)', 'timeFrame': 'For the duration of treatment, an average of 16 weeks', 'description': 'Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.'}, {'measure': 'Pharmacokinetics (PK) parameters of HDM201', 'timeFrame': 'Up to 42 days'}, {'measure': 'Changes from baseline of Pharmacodynamics markers', 'timeFrame': 'Baseline, up to 28 days'}, {'measure': 'Tumor response', 'timeFrame': 'Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment', 'description': 'end of treatment = 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)'], 'conditions': ['Advanced Solid and Hematological TP53wt Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17828', 'label': 'Study Results'}]}, 'descriptionModule': {'briefSummary': 'To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.\n* Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.\n\nOther protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Prior treatment with compounds with the same mode of action\n* Subjects with significant or uncontrolled cardiovascular disease\n* History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism\n* Previous and concomitant therapy that precludes enrollment, as defined in the protocol\n* Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection\n* Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery\n* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation\n* Pregnant or nursing women\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02143635', 'briefTitle': 'Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53', 'orgStudyIdInfo': {'id': 'CHDM201X2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Drug: HDM201', 'Drug: ancillary treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'interventionNames': ['Drug: HDM201']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'interventionNames': ['Drug: HDM201']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'interventionNames': ['Drug: HDM201']}], 'interventions': [{'name': 'HDM201', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'ancillary treatment', 'type': 'DRUG', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute SC-6', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Onc. Dep', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '104 0045', 'city': 'Chuo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '10041', 'city': 'Taipei', 'state': 'Taiwan ROC', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}