NCT01140607

Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment

Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	Cabazitaxel (XRP6258)	Pharmaceutical form:solution for infusion Route of administration: intravenous

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-06-09
• Last updated: 2015-07-21

Locations

14 sites across 1 country: United States