This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer
Completed · Phase 2
Conditions studied: Breast Neoplasms, Metastases, Neoplasm
In brief
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.
Key facts
- Study ID
- NCT00034918
- Run by
- Genzyme, a Sanofi Company
- People needed
- 44
- Starts
- 2002-05-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2016-08-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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?)
Where it is running
- Research Site — Indianapolis, Indiana, United States
- Research Site — Barcelona, Spain
Full record on ClinicalTrials.gov
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