Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: July 17, 2008
Last updated: March 8, 2013
Last verified: March 2013

July 17, 2008
March 8, 2013
July 2008
February 2013   (final data collection date for primary outcome measure)
Recommended dose of the combination based on Dose Limiting Toxicities observed [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00719524 on Archive Site
  • Overall safety profile [ Time Frame: Treatment period ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
  • Anti-tumor activity of the combination [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor
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.

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.

Not Provided
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dose escalation study with combination chemotherapy
Experimental: 1
Intervention: Drug: OMBRABULIN (AVE8062)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 2013   (final data collection date for primary outcome measure)

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.

18 Years and older
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Switzerland
TCD10620, EudraCT: 2007-006676-11
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP