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Effect of Cabazitaxel on the QTc Interval in Cancer Patients (QT-Cab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087021
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Neoplasms, Malignant Drug: Cabazitaxel (XRP6258) Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
Study Start Date : March 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution for infusion

Route of administration: intravenous


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in QT interval corrected calculation by Fridericia method [ Time Frame: Cycle 1, Day 1 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Other ECG parameters : PR, QRS intervals and ECG morphology [ Time Frame: Cycle 1, Day 1 ]
  3. 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 ]
  4. Cabazitaxel plasma concentrations, Cmax and partial AUC - [ Time Frame: Cycle 1, Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087021


Locations
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United States, California
Sanofi-Aventis Investigational Site Number 840006
San Diego, California, United States, 92103
Sanofi-Aventis Investigational Site Number 840002
San Francisco, California, United States, 94115
United States, Illinois
Sanofi-Aventis Investigational Site Number 840005
Decatur, Illinois, United States, 62526
United States, Kansas
Sanofi-Aventis Investigational Site Number 840008
Wichita, Kansas, United States, 67214
United States, Kentucky
Sanofi-Aventis Investigational Site Number 840010
Paducah, Kentucky, United States, 42002
United States, Missouri
Sanofi-Aventis Investigational Site Number 840007
Kansas City, Missouri, United States, 64128
United States, Pennsylvania
Sanofi-Aventis Investigational Site Number 840009
Bethlehem, Pennsylvania, United States, 18015
United States, Utah
Sanofi-Aventis Investigational Site Number 840003
Salt Lake City, Utah, United States, 84132
Belgium
Sanofi-Aventis Investigational Site Number 056002
Bruxelles, Belgium, 1200
Sanofi-Aventis Investigational Site Number 056001
Gent, Belgium, 9000
Denmark
Sanofi-Aventis Investigational Site Number 208002
Herlev, Denmark, 2730
Sanofi-Aventis Investigational Site Number 208001
København Ø, Denmark, 2100
Netherlands
Sanofi-Aventis Investigational Site Number 528001
Maastricht, Netherlands, 6229 HX
Sweden
Sanofi-Aventis Investigational Site Number 752002
Lund, Sweden, 221 85
Sanofi-Aventis Investigational Site Number 752001
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01087021    
Other Study ID Numbers: TES10884
2009-016864-35 ( EudraCT Number )
U1111-1116-5677 ( Other Identifier: UTN )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Neoplasms