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

Completed · Phase 1

Conditions studied: Neoplasm Malignant

In brief

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.

Key facts

Study ID

NCT01140607

Run by

Sanofi

People needed

56

Starts

2010-05-01

Expected to finish

2014-07-01

Last updated by the study team

2015-07-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a diagnosis of advanced, measurable or non-measurable, non-hematological cancer who have varying degrees of hepatic impairment. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists.

You may not qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2
• Life expectancy <3 months
• Need for a major surgical procedure or radiation therapy during the study
• Evidence of another active malignancy
• Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration
• Patients with known history of Gilbert's syndrome
• Prior treatment with Cabazitaxel and a history of severe (Grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures
• Prior history of bone marrow transplant
• Any treatment known to induce CYP isoenzymes or to inhibit CYP3A4 activities within 2 weeks before or during the test period of the pharmacokinetic sampling. Moderate inhibitors within one week prior and during the pharmacokinetic sampling.
• Any contra-indications to midazolam, according to the applicable labeling.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840014 — La Jolla, California, United States
• Investigational Site Number 840013 — Loma Linda, California, United States
• Investigational Site Number 840020 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840016 — Jacksonville, Florida, United States
• Investigational Site Number 840002 — Tampa, Florida, United States
• Investigational Site Number 840017 — Decatur, Illinois, United States
• Investigational Site Number 840003 — Metairie, Louisiana, United States
• Investigational Site Number 840019 — Baltimore, Maryland, United States
• Investigational Site Number 840012 — Boston, Massachusetts, United States
• Investigational Site Number 840001 — St Louis, Missouri, United States
• Investigational Site Number 840021 — Canton, Ohio, United States
• Investigational Site Number 840007 — Cincinnati, Ohio, United States
• Investigational Site Number 840010 — Bethlehem, Pennsylvania, United States
• Investigational Site Number 840006 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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