A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
Gemcitabine is given by vein over 30 minutes on days 1 & 8 of each 21-day cycle. LY231514 is
also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin
supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the
first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12
is administered approximately every 9 weeks after the first injection. Appropriate
antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is
given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to
prevent or lessen the possibility of a rash.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
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