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Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

NCT01308567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1168

Last updated 2019-06-05

Study results available
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Summary

Primary Objective:

* To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

* To evaluate safety in the 3 treatment arms.
* To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for:

* Progression Free Survival (PFS) (RECIST 1.1)
* Tumor progression free survival (RECIST 1.1)
* Tumor response in participants with measurable disease (RECIST 1.1),
* PSA response
* PSA-Progression free survival (PSA-PFS).
* Pain response in participants with stable pain at baseline
* Pain progression free survival
* Time to occurrence of any skeletal related events (SRE)
* To compare Health-Related Quality of Life (HRQL).
* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Conditions

Interventions

DRUG

Cabazitaxel (XRP6258)

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

DRUG

Docetaxel (XRP6976)

Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

DRUG

Prednisone

Pharmaceutical form: Tablet; Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-05
Primary Completion
2015-09-30
Completion
2018-05-31

Countries

  • United States
  • Australia
  • Belarus
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01308567 on ClinicalTrials.gov