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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
  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:


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
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: 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
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014