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

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.