Effect of Cabazitaxel on the QTc Interval in Cancer Patients

NCT01087021 | Completed Phase 1

• 3 other identifiers: TES108842009-016864-35U1111-1116-5677
• Study Type: interventional
• Target: 45
• Locations: 5 countries
• Sites: 15

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)

Conditions

Neoplasms, Malignant

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QT interval corrected calculation by Fridericia method

  Cycle 1, Day 1

Secondary Outcomes (4)

• 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

  Cycle 1, Day 1

• Other ECG parameters : PR, QRS intervals and ECG morphology

  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

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

• Cabazitaxel plasma concentrations, Cmax and partial AUC -

  Cycle 1, Day 1

Study Arms (1)

cabazitaxel

EXPERIMENTAL

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)

Interventions

Cabazitaxel (XRP6258) DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (15)

Sanofi-Aventis Investigational Site Number 840006

San Diego, California, 92103, United States

Location

Sanofi-Aventis Investigational Site Number 840002

San Francisco, California, 94115, United States

Location

Sanofi-Aventis Investigational Site Number 840005

Decatur, Illinois, 62526, United States

Location

Sanofi-Aventis Investigational Site Number 840008

Wichita, Kansas, 67214, United States

Location

Sanofi-Aventis Investigational Site Number 840010

Paducah, Kentucky, 42002, United States

Location

Sanofi-Aventis Investigational Site Number 840007

Kansas City, Missouri, 64128, United States

Location

Sanofi-Aventis Investigational Site Number 840009

Bethlehem, Pennsylvania, 18015, United States

Location

Sanofi-Aventis Investigational Site Number 840003

Salt Lake City, Utah, 84132, United States

Location

Sanofi-Aventis Investigational Site Number 056002

Brussels, 1200, Belgium

Location

Sanofi-Aventis Investigational Site Number 056001

Ghent, 9000, Belgium

Location

Sanofi-Aventis Investigational Site Number 208002

Herlev, 2730, Denmark

Location

Sanofi-Aventis Investigational Site Number 208001

København Ø, 2100, Denmark

Location

Sanofi-Aventis Investigational Site Number 528001

Maastricht, 6229 HX, Netherlands

Location

Sanofi-Aventis Investigational Site Number 752002

Lund, 221 85, Sweden

Location

Sanofi-Aventis Investigational Site Number 752001

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Neoplasms

Interventions

cabazitaxel; XRP6258

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

US (8); DK (2); BE (2); NL (1); SE (2)