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

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

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.

Treatment Details

Interventions

• Cabazitaxel (Taxane)

Participant Groups

Group I: Cohort 5: normal hepatic function: cabazitaxel and midazolam Experimental Treatment 1 Intervention

cabazitaxel 25mg/m\^2 IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks). Midazolam is given orally in single dosing on day -1 and day 1 (crossover)

Group II: Cohort 4: severe hepatic impairment: cabazitaxel Experimental Treatment 1 Intervention

cabazitaxel 5 mg/m\^2 or 10mg/m\^2 IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

Group III: Cohort 3: moderate hepatic impairment: cabazitaxel Experimental Treatment 1 Intervention

cabazitaxel 10mg/m\^2 IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

Group IV: Cohort 2: mild hepatic impairment : cabazitaxel Experimental Treatment 1 Intervention

cabazitaxel 20mg/m\^2 IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

Group V: Cohort 1: normal hepatic function: cabazitaxel Experimental Treatment 1 Intervention

cabazitaxel 25mg/m\^2 IV infusion of Cabazitaxel is given over 1 hour on Day 1 of each cycle (every 3 weeks).

Cabazitaxel is already approved in Canada, Japan for the following indications:

Approved in Canada as Jevtana for:

• Hormone-refractory metastatic prostate cancer

Approved in Japan as Jevtana for:

• Prostate cancer

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University