Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Cabazitaxel (XRP6258); Drug: prednisolone

• Registration Number: NCT01324583
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

* To assess the tolerability at global doses

Secondary Objectives:

* Safety

* Pharmacokinetics

* Efficacy

Detailed Description

The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Cabazitaxel (XRP6258)	Patients will receive cabazitaxel as the dose of corresponded level 1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m²
Arm 1	prednisolone	Patients will receive cabazitaxel as the dose of corresponded level 1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m²

Primary Outcome Measures

Name	Time	Method
Identification of maximum tolerated dose	up to 18 months

Secondary Outcome Measures

Name	Time	Method
Pharmakokinetic parameters of Cabazitaxel	up to 18 months
number of participants with treatment emergent adverse events	up to 18 months
Prostate Specific Antigen (PSA) Response	up to 18 months

Trial Locations

Locations (21)

Investigational Site Number 392011; 🇯🇵 Bunkyo-Ku, Japan

Investigational Site Number 392021; 🇯🇵 Fukuoka-Shi, Japan

Investigational Site Number 392014; 🇯🇵 Hamamatsu-Shi, Japan

Investigational Site Number 392009; 🇯🇵 Itabashi-Ku, Japan

Investigational Site Number 392001; 🇯🇵 Kashiwa-Shi, Japan

Investigational Site Number 392020; 🇯🇵 Kita-Gun, Japan

Investigational Site Number 392002; 🇯🇵 Koto-Ku, Japan

Investigational Site Number 392016; 🇯🇵 Kyoto-Shi, Japan

Investigational Site Number 392017; 🇯🇵 Kyoto-Shi, Japan

Investigational Site Number 392008; 🇯🇵 Maebashi-Shi, Japan

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