Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
NCT ID: NCT02524951
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2016-04-30
2018-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSI-1436C (Trodusquemine) 20 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 26 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 34 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 44 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 57 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 74 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
MSI-1436C (Trodusquemine) 96 mg/m2 IV
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.
MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Interventions
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MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
A metastatic site must be biopsy proven
* Life expectancy ≥3 months.
* Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
* Female Age ≥18 years.
* Stable brain metastasis is permitted. This is not considered measurable disease.
Stable 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
* A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age \< 55 or with no menses for \< 1 year
* Screening laboratory values as follows:
Total 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.
Serum 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
Exclusion Criteria
* ECOG Performance Status greater than 2
18 Years
FEMALE
No
Sponsors
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DepYmed Inc.
INDUSTRY
Northwell Health
OTHER
Responsible Party
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Daniel Budman
Director Translational Research, Cancer Institute
Principal Investigators
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Daniel Budman, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore LIJ Cancer Institute
Locations
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CFAM / Monter Cancer Center
Lake Success, New York, United States
Countries
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Other Identifiers
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IIS-0039
Identifier Type: -
Identifier Source: org_study_id
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