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Effect of Cabazitaxel on the QTc Interval in Cancer Patients

NCT ID: NCT01087021

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-11-30

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Neoplasms, Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cabazitaxel

At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2.

An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion.

Group Type EXPERIMENTAL

Cabazitaxel (XRP6258)

Intervention Type DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Interventions

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Cabazitaxel (XRP6258)

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Investigational Site Number 840006

San Diego, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840002

San Francisco, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840005

Decatur, Illinois, United States

Site Status

Sanofi-Aventis Investigational Site Number 840008

Wichita, Kansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840010

Paducah, Kentucky, United States

Site Status

Sanofi-Aventis Investigational Site Number 840007

Kansas City, Missouri, United States

Site Status

Sanofi-Aventis Investigational Site Number 840009

Bethlehem, Pennsylvania, United States

Site Status

Sanofi-Aventis Investigational Site Number 840003

Salt Lake City, Utah, United States

Site Status

Sanofi-Aventis Investigational Site Number 056002

Brussels, , Belgium

Site Status

Sanofi-Aventis Investigational Site Number 056001

Ghent, , Belgium

Site Status

Sanofi-Aventis Investigational Site Number 208002

Herlev, , Denmark

Site Status

Sanofi-Aventis Investigational Site Number 208001

København Ø, , Denmark

Site Status

Sanofi-Aventis Investigational Site Number 528001

Maastricht, , Netherlands

Site Status

Sanofi-Aventis Investigational Site Number 752002

Lund, , Sweden

Site Status

Sanofi-Aventis Investigational Site Number 752001

Uppsala, , Sweden

Site Status

Countries

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United States Belgium Denmark Netherlands Sweden

Other Identifiers

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2009-016864-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1116-5677

Identifier Type: OTHER

Identifier Source: secondary_id

TES10884

Identifier Type: -

Identifier Source: org_study_id