Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
Stopped early · Phase 1
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02524951
- Run by
- Northwell Health
- People needed
- 5
- Starts
- 2016-04-01
- Expected to finish
- 2018-05-14
- Last updated by the study team
- 2018-05-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant or breast-feeding
- ECOG Performance Status greater than 2
Where it is running
- CFAM / Monter Cancer Center — Lake Success, New York, United States
Full record on ClinicalTrials.gov
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