NCT00547261

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

October 18, 2007

Last Update Submit

April 16, 2009

Conditions

Neoplasms

Keywords

solid tumorantimitotictubulin binder

Outcome Measures

Primary Outcomes (1)

  • Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)

    Study period

Secondary Outcomes (1)

  • Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity

    Study period

Study Arms (2)

Arm A

EXPERIMENTAL

1 hour IV infusion D1

Drug: SSR97225

Arm B

EXPERIMENTAL

1 hour IV infusion D1, D8, D15

Drug: SSR97225

Interventions

SSR97225DRUG

every 3 weeks

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 22, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

US(1)