Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer

Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors

The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.

Inclusion Criteria:

• Diagnosis of metastatic or locally advanced non-hematological cancer
• Patients with solid tumors refractory to therapy or for whom no therapy exists

Exclusion Criteria:

• Five or more prior chemotherapy lines for metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Patients having discontinued previous specific anti-cancer treatment
• Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia)
• Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment
• No adequate birth control methods

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