Neoplasm Malignant Clinical Trial
Official title:
An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
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have not met study withdrawn criteria.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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