Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-06-20 @ 5:18 AM
Study NCT ID:
NCT02524951
Status:
TERMINATED
Last Update Posted:
2018-05-18
First Post:
2015-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C441128', 'term': '3-N-1(spermine)-7, 24-dihydroxy-5-cholestane 24-sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'lack of interest by sponsor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2015-08-12', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximally Tolerated Dose (MTD) of MSI-1436', 'timeFrame': 'one year', 'description': 'Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436C. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436C will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'one year', 'description': 'The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to drug after administration of a dose of MSI-1436C.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'one year', 'description': 'All adverse events and dose-limiting toxicities will be recorded and tabulated. A dose-limiting toxicity (DLT) will be defined as any grade 3 or higher NCI Common Toxicity Criteria adverse event (CTCAE) that is deemed related to the study drug MSI-1436C, any infusion reaction necessitating drug discontinuation, or any other drug related adverse event leading to the study drug discontinuation.\n\nDescriptive statistics will be used to summarize adverse events and dose-limiting toxicities. The proportion of AEs and DLTs will be calculated along with their corresponding exact 95% confidence intervals.'}, {'measure': 'response rates', 'timeFrame': 'one year', 'description': "To assess the response rates of MSI-1436C in metastatic breast cancer patients the outcome variable of interest is time-to-progression. Patients who have not progressed (or who have not died) as of their last known follow-up, will be considered 'censored' for the time-to-progression analysis.\n\nTime-to-progression will be estimated using the Kaplan-Meier Product-Limit Method. Any post- hoc group comparisons will be carried out using the log-rank test. Patients who have not progressed (or who have not died) as of their last known follow-up, will be considered 'censored' for the time-to-progression analysis."}, {'measure': 'Peak plasma concentration of the drug after administration (cmax)', 'timeFrame': 'one year', 'description': 'The maximum (or peak) serum concentration that MSI-1436C achieves in the plasma after the drug has been administrated and prior to the administration of a second dose.'}, {'measure': 'Time to reach cmax', 'timeFrame': 'one year', 'description': 'The amount of time for MSI-1436C to reach Cmax'}, {'measure': 'Time required for the concentration of MSI-1436C to reach half of its original value, or half life (t1/2)', 'timeFrame': 'one year', 'description': 'The time required for the concentration of MSI-1436C to reach half of its original value.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.', 'detailedDescription': 'This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).\n* Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.\n\nA metastatic site must be biopsy proven\n\n* Life expectancy ≥3 months.\n* Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.\n* Female Age ≥18 years.\n* Stable brain metastasis is permitted. This is not considered measurable disease.\n\nStable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks\n\n* A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age \\< 55 or with no menses for \\< 1 year\n* Screening laboratory values as follows:\n\nTotal bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN.\n\nSerum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count \\>1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* ECOG Performance Status greater than 2'}, 'identificationModule': {'nctId': 'NCT02524951', 'briefTitle': 'Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'IIS-0039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 20 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 20 mg/m2. Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 26 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 26 mg/m2. Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 34 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 34 mg/m2 . Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 44 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 44 mg/m2 . Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 57 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 57 mg/m2. Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 74 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 74 mg/m2 . Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}, {'type': 'EXPERIMENTAL', 'label': 'MSI-1436C (Trodusquemine) 96 mg/m2 IV', 'description': 'Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 96 mg/m2 . Drug infusions will last approximately 2 hours.', 'interventionNames': ['Drug: MSI-1436C']}], 'interventions': [{'name': 'MSI-1436C', 'type': 'DRUG', 'otherNames': ['Trodusquemine'], 'description': 'Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.', 'armGroupLabels': ['MSI-1436C (Trodusquemine) 20 mg/m2 IV', 'MSI-1436C (Trodusquemine) 26 mg/m2 IV', 'MSI-1436C (Trodusquemine) 34 mg/m2 IV', 'MSI-1436C (Trodusquemine) 44 mg/m2 IV', 'MSI-1436C (Trodusquemine) 57 mg/m2 IV', 'MSI-1436C (Trodusquemine) 74 mg/m2 IV', 'MSI-1436C (Trodusquemine) 96 mg/m2 IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'CFAM / Monter Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}], 'overallOfficials': [{'name': 'Daniel Budman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore LIJ Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'DepYmed Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Translational Research, Cancer Institute', 'investigatorFullName': 'Daniel Budman', 'investigatorAffiliation': 'Northwell Health'}}}}