Neoplasm Malignant Clinical Trial
Official title:
Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment
Primary Objectives:
- To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when
administered to advanced solid tumor patients with varying degrees of hepatic
impairment
- To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees
of hepatic impairment
- To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide
prescribers with regard to dosing in this patient population
- To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme
activity using midazolam as probe in an additional cohort of cancer patients with
normal hepatic function.
The study consists of:
- a screening phase (maximum length of 21-day).
- a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up
to maximum of 12 additional days in case of unresolved toxicity.
Patients continue to receive treatment until they experience, unacceptable toxicities/AEs,
disease progression ,withdraw their consent, or the investigator decides to discontinue the
patient, or study cut-off, whichever comes first.
- a 30-day follow-up visit after the last dose of study medication.
The cut off date is when the last patient treated has completed cycle 1 and the subsequent
30 days follow-up.
Patients may continue to be treated as long as they are benefiting from study treatment and
have not met study withdrawal criteria.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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