Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/20/2018 |
| Start Date: | April 2016 |
| End Date: | May 14, 2018 |
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.
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.
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.
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
We found this trial at
1
site
Lake Success, New York 11042
Principal Investigator: Daniel Budman, MD
Phone: 516-734-8958
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