Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Not provided
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 392008
🇯🇵Maebashi-Shi, Japan
Investigational Site Number 392015
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392003
🇯🇵Sunto-Gun, Japan
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 392012
🇯🇵Minato-Ku, Japan
Investigational Site Number 392019
🇯🇵Osaka Sayama-Shi, Japan
Investigational Site Number 392004
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392005
🇯🇵Sendai-Shi, Japan
Investigational Site Number 392010
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392018
🇯🇵Suita-Shi, Japan
Investigational Site Number 392007
🇯🇵Tsukuba-Shi, Japan
Investigational Site Number 392013
🇯🇵Yokohama-Shi, Japan
Investigational Site Number 392006
🇯🇵Yamagata-Shi, Japan