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

This study has been terminated.
(Due to lack of supply of the investigational product.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00547261
First received: October 18, 2007
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Neoplasms
Drug: SSR97225
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Maximal tolerated dose (MTD) and dose limiting toxicity (DLT) [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity [ Time Frame: Study period ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: October 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547261

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00547261     History of Changes
Other Study ID Numbers: TED5710
Study First Received: October 18, 2007
Last Updated: April 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
solid tumor
antimitotic
tubulin binder

ClinicalTrials.gov processed this record on November 24, 2014