This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer
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An Open-label, Multicenter Phase II Study to Assess the Response of Subjects With Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy With or Without Capecitabine to ZD6474 (100-mg or 300-mg Daily Oral Dose).
Study Start Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies;
WHO performance status 0, 1 or 2 on the day of registration;
Females, aged >= 18 years;
No Gastrointestinal pathology which could affect the bioavailability of ZD6474.
Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV).
Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia;
History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia;
Chronic atrial fibrillation;
Previous history of QT / QTc prolongation with other medication;
Congenital long QT syndrome;
Systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, or suramin);
Currently receiving drugs with known significant 3A4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects;
Currently receiving therapeutic doses of warfarin (Coumadin?)