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Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment

Phase 1
18 Years
Open (Enrolling)
Neoplasm Malignant

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Trial Information

Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients With Varying Degrees of Hepatic Impairment

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.

Inclusion 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (DLT)

Outcome Description:

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.

Outcome Time Frame:

cycle 1 (3 weeks)

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms



Investigational Site Number 840007 Cincinnati, Ohio  45267-0542
Investigational Site Number 840013 Loma Linda, California  92354
Investigational Site Number 840014 San Francisco, California  94143
Investigational Site Number 840020 Washington, District of Columbia  20037
Investigational Site Number 840016 Jacksonville, Florida  32207
Investigational Site Number 840002 Tampa, Florida  33612
Investigational Site Number 840017 Decatur, Illinois  62526
Investigational Site Number 840003 Metairie, Louisiana  70006
Investigational Site Number 840019 Baltimore, Maryland  21201
Investigational Site Number 840012 Boston, Massachusetts  02115
Investigational Site Number 840001 St Louis, Missouri  63110
Investigational Site Number 840021 Canton, Ohio  44718
Investigational Site Number 840010 Bethlehem, Pennsylvania  18015
Investigational Site Number 840006 San Antonio, Texas  78229
Investigational Site Number 840024 Augusta, Georgia  30912
Investigational Site Number 840022 Indianapolis, Indiana  46202
Investigational Site Number 840004 Detroit, Michigan  48201