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

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.
ClinicalTrials.gov Identifier: NCT00699517
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Sarcoma Drug: OMBRABULIN (AVE8062) Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2008
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: until event or study cut-off date (Tumor assessment every 6 weeks) ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: until event or study cut-off date ]
  2. Response rate [ Time Frame: tumor assessment every 6 weeks ]
  3. Safety profile [ Time Frame: assessment every 3 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00699517


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00699517     History of Changes
Other Study ID Numbers: EFC10145
EudraCT 2007-003592-39
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: November 2015

Keywords provided by Sanofi:
tubulin modulator
endothelium
combretastatin
cisplatin

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Isophosphamide mustard
Cisplatin
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action