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

NCT01527929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-12-04

No results posted yet for this study

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

Conditions

  • Neoplasm Malignant

Interventions

DRUG

Cabazitaxel XRP6258

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Belgium
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527929 on ClinicalTrials.gov