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

NCT ID: NCT00547261

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

1 hour IV infusion D1

Group Type EXPERIMENTAL

SSR97225

Intervention Type DRUG

every 3 weeks

Arm B

1 hour IV infusion D1, D8, D15

Group Type EXPERIMENTAL

SSR97225

Intervention Type DRUG

every 3 weeks

Interventions

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SSR97225

every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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TED5710

Identifier Type: -

Identifier Source: org_study_id

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