NCT00034918

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

First QC Date

May 2, 2002

Last Update Submit

August 22, 2016

Conditions

Breast NeoplasmsMetastases, Neoplasm

Keywords

Metastatic breast cancer

Interventions

ZD6474DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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?)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Indianapolis, Indiana, United States

Location

Research Site

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

May 1, 2002

Study Completion

November 1, 2003

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

US(1)ES(1)