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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01140607
First received: May 28, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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

Condition Intervention Phase
Neoplasm Malignant
Drug: Cabazitaxel (XRP6258)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: Yes ]
    A clinical adverse event or a laboratory abnormality is defined as DLT when it is drug-related as assessed by the investigator and agreed upon by the study committee.


Secondary Outcome Measures:
  • Safety investigations (physical examination, vital signs and laboratory tests) [ Time Frame: up to 30 days after the last dosing ] [ Designated as safety issue: Yes ]

    Physical examination includes Eastern Cooperative Oncology Group (ECOG) performance status and signs and symptoms.

    Vital signs includes weight, temperature, blood pressure and heart rate.

    Laboratory tests includes hematology, coagulation, biochemistry and urinalysis. Laboratory abnormalities are graded according to the NCI CTCAE v.4.0


  • Pharmacokinetic profile of Cabazitaxel (AUC, Cmax, t1/2, CL, and Vss) from plasma concentration [ Time Frame: cycle 1 (3 weeks) ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cabazitaxel
  • Cohort 1 - normal hepatic function : cabazitaxel 25mg/m2;
  • Cohort 2 - mild hepatic impairment : cabazitaxel 20mg/m2;
  • Cohort 3 - moderate to severe hepatic impairment: cabazitaxel 10mg/m2;

IV infusion is given over 1 hour on Day1 of each cycle (every 3 weeks).

Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution for infusion

Route of administration: intravenous


Detailed Description:

The study consists of:

  • a screening phase (maximum length of 21-day).
  • a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up to maximum of 12 additional days in case of unresolved toxicity.

Patients continue to receive treatment until they experience, unacceptable toxicities/AEs, disease progression ,withdraw their consent, or the investigator decides to discontinue the patient, or study cut-off, whichever comes first.

  • a 30-day follow-up visit after the last dose of study medication.

The cut off date is when the last patient treated has completed cycle 1 and the subsequent 30 days follow-up.

Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawal criteria.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2
  • Life expectancy <3 months
  • Need for a major surgical procedure or radiation therapy during the study
  • Evidence of another active malignancy
  • Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration
  • Patients with known history of Gilbert's syndrome
  • Prior treatment with Cabazitaxel and a history of severe (Grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140607

Locations
United States, California
Investigational Site Number 840014
La Jolla, California, United States, 92093
Investigational Site Number 840013
Loma Linda, California, United States, 92354
United States, District of Columbia
Investigational Site Number 840020
Washington, District of Columbia, United States, 20037
United States, Florida
Investigational Site Number 840016
Jacksonville, Florida, United States, 32207
Investigational Site Number 840002
Tampa, Florida, United States, 33612
United States, Illinois
Investigational Site Number 840017
Decatur, Illinois, United States, 62526
United States, Louisiana
Investigational Site Number 840003
Metairie, Louisiana, United States, 70006
United States, Maryland
Investigational Site Number 840019
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Investigational Site Number 840012
Boston, Massachusetts, United States, 02115
United States, Missouri
Investigational Site Number 840001
St Louis, Missouri, United States, 63110
United States, Ohio
Investigational Site Number 840021
Canton, Ohio, United States, 44718
Investigational Site Number 840007
Cincinnati, Ohio, United States, 45267-0542
United States, Pennsylvania
Investigational Site Number 840010
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
Investigational Site Number 840006
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01140607     History of Changes
Other Study ID Numbers: POP6792, U1111-1116-5845
Study First Received: May 28, 2010
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014