Expired Study
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Indianapolis, Indiana


Purpose:

The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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?)


NCT ID:

NCT00034918


Primary Contact:

Study Director
Clinical Sciences & Operations
Sanofi


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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