Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer
- Registration Number
- NCT00547261
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A SSR97225 1 hour IV infusion D1 Arm B SSR97225 1 hour IV infusion D1, D8, D15
- Primary Outcome Measures
Name Time Method Maximal tolerated dose (MTD) and dose limiting toxicity (DLT) Study period
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity Study period
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇸Bridgewater, New Jersey, United States