NCT01527929

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

An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Conditions

• Neoplasm Malignant

Interventions

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

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-07
• Last updated: 2013-12-04

Locations

7 sites across 5 countries: Belgium, Italy, Netherlands, Spain, United Kingdom