Status:
COMPLETED
AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor
Lead Sponsor:
Sanofi
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00719524
Start Date
July 1 2008
End Date
February 1 2013
Last Update
March 11 2013
Active Locations (3)
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1
Investigational Site Number 250001
Villejuif, France, 94805
2
Investigational Site Number 380001
Milan, Italy, 20133
3
Investigational Site Number 756001
Bellinzona, Switzerland, 6500