NCT00723086

Brief Summary

The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

July 24, 2008

Last Update Submit

September 30, 2009

Conditions

Therapy, Prostatic Neoplasms

Keywords

docetaxel, prednisolone, drug combination

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0)

    First treatment up to 37 months

Secondary Outcomes (1)

  • No obvious disease progression

    First treatment up to 37 months

Interventions

docetaxel (XRP6976)DRUG

combined treatment with prednisolone

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.

You may not qualify if:

  • Continuation in the study would be detrimental to the patient's well-being
  • Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing
  • Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion)
  • Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

May 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

JP(1)