NCT00498797

Brief Summary

The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 2005

Geographic Reach
5 countries

11 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

December 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
Last Updated

October 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

July 9, 2007

Results QC Date

April 27, 2011

Last Update Submit

August 25, 2016

Conditions

Prostate CancerMetastaticHormone Refractory

Keywords

prostate cancerzactimavandetanibmetastatic

Outcome Measures

Primary Outcomes (1)

  • Prostate Specific Antigen (PSA) Response

    Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response

    PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline

Secondary Outcomes (1)

  • Number of Patients With an Objective Disease Progression Event

    RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)

Interventions

Zactima (vandetanib)DRUG
DocetaxelDRUG
PrednisoloneDRUG

Eligibility Criteria

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

You may qualify if:

  • Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA
  • No previous chemotherapy although those patients that have received estramustine can enter the study provided the estramustine was stopped 3 weeks before dosing of study drug
  • screening PSA values \>20ng/ml. this must be confirmed by two separate measurements at least 2 weeks apart

You may not qualify if:

  • Treatment within 4 weeks before randomization and/or whilst on study, treatment with the following: 1)non-approved or experimental drug, 2)treatment with a drug with similar mechanism of action to ZD6474
  • concurrent treatment with other anticancer agents, othr than docetaxel and prednisolone as defined in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research site

Rio de Janeiro, Brazil

Location

Research Site

São Paulo, Brazil

Location

Research Site

Hamburg, Germany

Location

Research Site

Hanover, Germany

Location

Research Site

Kassel, Germany

Location

Research Site

Tübingen, Germany

Location

Research Site

Budapest, Hungary

Location

Research Site

Bloemfontein, South Africa

Location

Research Site

Cape Town, South Africa

Location

Research Site

Umeå, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

vandetanibDocetaxelPrednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

December 1, 2005

Primary Completion

July 1, 2007

Study Completion

September 1, 2008

Last Updated

October 7, 2016

Results First Posted

May 24, 2011

Record last verified: 2016-08

Locations

ZA(2)SE(2)DE(4)HU(1)BR(2)