Primary Objective: \- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: \- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first. Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Pharmaceutical form: solution for infusion Route of administration: intravenous
Investigational Site Number 056002
Brussels, Belgium
Investigational Site Number 056001
Ghent, Belgium
Investigational Site Number 380001
Milan, Italy
Investigational Site Number 528001
Rotterdam, Netherlands
Pharmacokinetic profile of cabazitaxel in study population
Time frame: Up to day 10
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
Time frame: up to 30 days after the last dosing
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Investigational Site Number 528002
Utrecht, Netherlands
Investigational Site Number 724001
Barcelona, Spain
Investigational Site Number 826001
Cambridge, United Kingdom