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

Phase 2

Completed

• Conditions: Metastases, Neoplasm; Breast Neoplasms

• Registration Number: NCT00034918
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Study Completion: 2003-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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?)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (1)

Research Site; 🇪🇸 Barcelona, Spain