AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor

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: NCT00719524
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: OMBRABULIN (AVE8062) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.
Study Start Date : July 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: 1 Drug: OMBRABULIN (AVE8062)
Dose escalation study with combination chemotherapy

Primary Outcome Measures :
  1. Recommended dose of the combination based on Dose Limiting Toxicities observed [ Time Frame: Cycle 1 ]

Secondary Outcome Measures :
  1. Overall safety profile [ Time Frame: Treatment period ]
  2. Pharmacokinetic profile [ Time Frame: Cycle 1 ]
  3. Anti-tumor activity of the combination [ Time Frame: Every 2 cycles ]

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:

  • Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

  • Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
  • Absence of histologically or cytologically proven cancer at the first diagnosis.
  • Negative serum/urinary pregnancy test
  • Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment

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): NCT00719524

Investigational Site Number 250001
Villejuif, France, 94805
Investigational Site Number 380001
Milano, Italy, 20133
Investigational Site Number 756001
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00719524     History of Changes
Other Study ID Numbers: TCD10620
EudraCT: 2007-006676-11
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Sanofi:
Antineoplastic Combined Chemotherapy Protocol

Additional relevant MeSH terms:
Antineoplastic Agents