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

Breast Neoplasms Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034918
• Other study ID #: 6474IL/0002
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: August 22, 2016
• Start date: May 2002
• Est. completion date: November 2003

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• ZD6474

Locations

Country	Name	City	State
Spain	Research Site	Barcelona
United States	Research Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Spain,