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

Stopped early · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00547261

Run by

Sanofi

People needed

6

Starts

2007-10-01

Expected to finish

2008-08-01

Last updated by the study team

2009-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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