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

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034918

Enrollment

Registered

2002-05-03

Start date

2002-05-31

Completion date

2003-11-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Metastases, Neoplasm

Keywords

Metastatic breast cancer

Brief summary

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

Interventions

DRUGZD6474

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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?)

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026