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

Phase 1

Terminated

• Conditions: Neoplasms
• Interventions: Drug: SSR97225

• 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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-22
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-16
• Last Update Posted: 2009-04-17

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