NCT00494481

Brief Summary

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Trial Health

93
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
5 countries

12 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

January 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
Last Updated

September 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

June 28, 2007

Results QC Date

April 27, 2011

Last Update Submit

August 24, 2016

Conditions

Advanced Breast Cancer

Keywords

Zactima

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With a Disease Progression Event

    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

    RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off

Study Arms (2)

1

PLACEBO COMPARATOR

Docetaxel + placebo vandetanib

Drug: Docetaxel

2

EXPERIMENTAL

Vandetanib + Docetaxel

Drug: Vandetanib (ZD6474)Drug: Docetaxel

Interventions

Vandetanib (ZD6474)DRUG

once daily oral dose

Also known as: ZACTIMA™
2
DocetaxelDRUG

intravenous infusion

Also known as: Taxotere®
12

Eligibility Criteria

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

You may qualify if:

  • Females with histological/cytological confirmation of breast cancer.
  • Subjects with a measurable lesion or bone lesions

You may not qualify if:

  • Previous radiotherapy within 6 weeks
  • Significant cardiac events, arrhythmias or other cardiac conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Budapest, Hungary

Location

Research Site

Pécs, Hungary

Location

Research SIte

Bloemfontein, South Africa

Location

Research Site

Cape Town, South Africa

Location

Research Site

Observatory, South Africa

Location

Research Site

Barakaldo, Spain

Location

Research SIte

Lleida, Spain

Location

Research Site

Zaragoza, Spain

Location

Research Site

Umeå, Sweden

Location

Research Site

Uppsala, Sweden

Location

Research Site

Västerås, Sweden

Location

Research Site

Taipei, Taiwan

Location

MeSH Terms

Interventions

vandetanibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

January 1, 2009

Last Updated

September 30, 2016

Results First Posted

May 24, 2011

Record last verified: 2016-08

Locations

HU(2)ES(3)SE(3)ZA(3)TW(1)