Effect of Cabazitaxel on the QTc Interval in Cancer Patients

Sanofi45 enrolled

Overview

Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)

The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles). After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms, Malignant

Interventions

Cabazitaxel (XRP6258)DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered. Exclusion criteria: * Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter * QTcF \>480 msec on screening Electrocardiogram (ECG) * Significant hypokalemia at screening (serum potassium \<3.5 mMol/L) * Significant hypomagnesemia at screening (serum magnesium \<0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities) * Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (15)

Sanofi-Aventis Investigational Site Number 840006

San Diego, California, United States

Sanofi-Aventis Investigational Site Number 840002

San Francisco, California, United States

Outcomes

Primary Outcomes

Change from baseline in QT interval corrected calculation by Fridericia method

Time frame: Cycle 1, Day 1

Secondary Outcomes

Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals

Time frame: Cycle 1, Day 1

Other ECG parameters : PR, QRS intervals and ECG morphology

Time frame: Cycle 1, Day 1

Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling

Time frame: up to treatment discontinuation + 30 days over a maximum study period of 20 months

Cabazitaxel plasma concentrations, Cmax and partial AUC -

Time frame: Cycle 1, Day 1

Data from ClinicalTrials.gov

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