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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547261
Recruitment Status : Terminated (Due to lack of supply of the investigational product.)
First Posted : October 22, 2007
Last Update Posted : April 17, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: SSR97225 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: Arm A
1 hour IV infusion D1
Drug: SSR97225
every 3 weeks

Experimental: Arm B
1 hour IV infusion D1, D8, D15
Drug: SSR97225
every 3 weeks

Primary Outcome Measures :
  1. Maximal tolerated dose (MTD) and dose limiting toxicity (DLT) [ Time Frame: Study period ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity [ Time Frame: Study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547261

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00547261     History of Changes
Other Study ID Numbers: TED5710
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
solid tumor
tubulin binder