Spots Global Cancer Trial Database for Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
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Trial Identification
Brief Title: Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Official Title: An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Study ID: NCT01324583
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Investigational Site Number 392012, Minato-Ku, , Japan
Investigational Site Number 392015, Nagoya-Shi, , 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 392003, Sunto-Gun, , Japan
Investigational Site Number 392007, Tsukuba-Shi, , Japan
Investigational Site Number 392006, Yamagata-Shi, , Japan
Investigational Site Number 392013, Yokohama-Shi, , Japan
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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