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

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: Cabazitaxel XRP6258

• Registration Number: NCT01527929
• Lead Sponsor: Sanofi

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Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Study Start: 2012-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C	Cabazitaxel XRP6258	Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
Cohort B	Cabazitaxel XRP6258	Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
Cohort A	Cabazitaxel XRP6258	Normal renal function - Cabazitaxel administered once every 3 weeks

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of cabazitaxel in study population	Up to day 10

Secondary Outcome Measures

Name	Time	Method
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters	up to 30 days after the last dosing

Trial Locations

Locations (7)

Investigational Site Number 056002; 🇧🇪 Bruxelles, Belgium

Investigational Site Number 056001; 🇧🇪 Gent, Belgium

Investigational Site Number 528002; 🇳🇱 Utrecht, Netherlands

Investigational Site Number 724001; 🇪🇸 Barcelona, Spain

Investigational Site Number 528001; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 380001; 🇮🇹 Milano, Italy

Investigational Site Number 826001; 🇬🇧 Cambridge, United Kingdom