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A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00699517
First received: May 7, 2008
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

  • To compare the overall survival in the 2 treatment arms
  • To compare the objective response rate in the 2 treatment arms
  • To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
  • To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

Condition Intervention Phase
Sarcoma
 Drug: OMBRABULIN (AVE8062)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: until event or study cut-off date (Tumor assessment every 6 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: until event or study cut-off date ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: tumor assessment every 6 weeks ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: assessment every 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 355
Study Start Date: June 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: OMBRABULIN (AVE8062)
I.V. infusion followed by administration of cisplatin
Placebo Comparator: 2 Drug: Placebo
I.V. infusion followed by administration of cisplatin

  Eligibility

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

Inclusion criteria:

  • Histologically proven soft tissue sarcoma
  • Unresectable locoregional recurrent or metastatic soft tissue sarcoma
  • Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy

Exclusion criteria:

  • Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
  • Brain metastases and carcinomatous leptomeningitis
  • Uncontrolled hypertension
  • Known platinum hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699517

  Show 45 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00699517     History of Changes
Other Study ID Numbers: EFC10145, EudraCT 2007-003592-39
Study First Received: May 7, 2008
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
tubulin modulator
endothelium
combretastatin
cisplatin

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Ifosfamide
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013