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).

Genzyme, a Sanofi Company3 个研究点分布在 2 个国家目标入组 44 人开始时间: 2002年5月1日最近更新: 2016年8月24日

适应症

试验速览

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

•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?)

发起方

Genzyme, a Sanofi Company

申办方类型

Industry

责任方

Sponsor

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