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Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

NCT01254279 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2015-01-21

No results posted yet for this study

Summary

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients.

Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

CABAZITAXEL

Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • Hungary
  • India
  • Ireland
  • Italy
  • Kazakhstan
  • Luxembourg
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • Slovakia
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254279 on ClinicalTrials.gov