This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer

Genzyme

Status and phase

Completed

Phase 2

Conditions

Metastases, Neoplasm

Breast Neoplasms

Treatments

Drug: ZD6474

Study type

Interventional

Funder types

Industry

Identifiers

6474IL/0002

Details and patient eligibility

About

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

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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?)