An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
Overview
- Phase
- Phase 1
- Intervention
- Cabazitaxel XRP6258
- Conditions
- Neoplasm Malignant
- Sponsor
- Sanofi
- Enrollment
- 25
- Locations
- 7
- Primary Endpoint
- Pharmacokinetic profile of cabazitaxel in study population
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A
Normal renal function - Cabazitaxel administered once every 3 weeks
Intervention: Cabazitaxel XRP6258
Cohort B
Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks
Intervention: Cabazitaxel XRP6258
Cohort C
Severe renal dysfunction - Cabazitaxel administered once every 3 weeks
Intervention: Cabazitaxel XRP6258
Outcomes
Primary Outcomes
Pharmacokinetic profile of cabazitaxel in study population
Time Frame: Up to day 10
Secondary Outcomes
- 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)