Spots Global Cancer Trial Database for Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

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Trial Identification

Brief Title: Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

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

Study ID: NCT01527929

Conditions

Neoplasm Malignant

Interventions

Cabazitaxel XRP6258

Study Description

Brief Summary: 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

Detailed Description: 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 Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.