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Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02524951
Recruitment Status : Terminated (lack of interest by sponsor)
First Posted : August 17, 2015
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
DepYmed Inc.
Information provided by (Responsible Party):
Daniel Budman, Northwell Health

Tracking Information
First Submitted Date  ICMJE August 12, 2015
First Posted Date  ICMJE August 17, 2015
Last Update Posted Date May 18, 2018
Study Start Date  ICMJE April 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
Maximally Tolerated Dose (MTD) of MSI-1436 [ Time Frame: one year ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02524951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: one year ]
    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.
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: one year ]
    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. Descriptive 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.
  • response rates [ Time Frame: one year ]
    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. Time-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.
  • Peak plasma concentration of the drug after administration (cmax) [ Time Frame: one year ]
    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.
  • Time to reach cmax [ Time Frame: one year ]
    The amount of time for MSI-1436C to reach Cmax
  • Time required for the concentration of MSI-1436C to reach half of its original value, or half life (t1/2) [ Time Frame: one year ]
    The time required for the concentration of MSI-1436C to reach half of its original value.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
Official Title  ICMJE A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Other Name: Trodusquemine
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
  • Experimental: 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.
    Intervention: Drug: MSI-1436C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2015)
21
Actual Study Completion Date  ICMJE May 14, 2018
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
  • 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:

  • Pregnant or breast-feeding
  • ECOG Performance Status greater than 2
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02524951
Other Study ID Numbers  ICMJE IIS-0039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Budman, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE DepYmed Inc.
Investigators  ICMJE
Principal Investigator: Daniel Budman, MD North Shore LIJ Cancer Institute
PRS Account Northwell Health
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP