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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).


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Metastases, Neoplasm

Thank you

Trial Information

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).


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?)

Type of Study:

Interventional

Study Design:

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

Principal Investigator

ZD6474 Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

6474IL/0002

NCT ID:

NCT00034918

Start Date:

May 2002

Completion Date:

November 2003

Related Keywords:

  • Breast Neoplasms
  • Metastases, Neoplasm
  • Metastatic breast cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Research SiteBloomington, Indiana