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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 ]
Same as current
Complete list of historical versions of study NCT00719524 on Archive Site
  • Overall safety profile [ Time Frame: Treatment period ]
  • Pharmacokinetic profile [ Time Frame: Cycle 1 ]
  • Anti-tumor activity of the combination [ Time Frame: Every 2 cycles ]
Same as current
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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
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dose escalation study with combination chemotherapy
Experimental: 1
Intervention: Drug: OMBRABULIN (AVE8062)
Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.

*   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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Switzerland
EudraCT: 2007-006676-11
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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