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

Sanofi

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: SSR97225

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547261

TED5710

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Arm A

Experimental group

Description:

1 hour IV infusion D1

Treatment:

Drug: SSR97225

Arm B

Experimental group

Description:

1 hour IV infusion D1, D8, D15

Treatment:

Drug: SSR97225