Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Phase 4

Completed

• Conditions: Prostate Cancer Metastatic
• Interventions: Drug: CABAZITAXEL XRP6258; Drug: Prednisone; Drug: Prednisolone

• Registration Number: NCT02074137
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer

Secondary Objectives:

1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer

2. To describe patient profile in terms of demography, disease characteristics and prior treatment history

3. To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response

Detailed Description

The study consists of:

* a screening phase (maximum length of 7-day).

* a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent.

* a 30-day follow-up visit after the last dose of study medication.

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2014-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabazitaxel	CABAZITAXEL XRP6258	Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Cabazitaxel	Prednisone	Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Cabazitaxel	Prednisolone	Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily

Primary Outcome Measures

Name	Time	Method
Number of patients with Related Serious Adverse Events	up to13 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications	up to 13 months
Radiological overall response (if radiological tumor assessment done) using Recist criteria	up to 13 months
Number of patients with at least 50% decrease in PSA	up to 13 months

Trial Locations

Locations (3)

Investigational Site Number 356003; 🇮🇳 New Delhi, India

Investigational Site Number 356005; 🇮🇳 Kollkata, India

Investigational Site Number 356002; 🇮🇳 Trivandrum, India