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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00034918
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Metastases, Neoplasm
Drug: ZD6474
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 44
Study Start Date: May 2002
Study Completion Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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?)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034918

Locations
United States, Indiana
Research Site
Indianapolis, Indiana, United States
Spain
Research Site
Barcelona, Spain, 08035
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: ZD6474 Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034918     History of Changes
Other Study ID Numbers: 6474IL/0002
Study First Received: May 2, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014