ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    msi-1436
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

August 12, 2015
August 17, 2015
May 18, 2018
April 2016
July 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02524951 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients
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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: MSI-1436C
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Other Name: Trodusquemine
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
21
May 14, 2018
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02524951
IIS-0039
Yes
Not Provided
Plan to Share IPD: No
Daniel Budman, Northwell Health
Northwell Health
DepYmed Inc.
Principal Investigator: Daniel Budman, MD North Shore LIJ Cancer Institute
Northwell Health
May 2018

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