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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034918
First Posted: May 3, 2002
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
May 2, 2002
May 3, 2002
August 24, 2016
May 2002
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Complete list of historical versions of study NCT00034918 on ClinicalTrials.gov Archive Site
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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).
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Metastases, Neoplasm
Drug: ZD6474
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2003
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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?)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain,   United States
 
 
NCT00034918
6474IL/0002
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Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP