Status:
COMPLETED
A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objective: * To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxe...
Detailed Description
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination w...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.
- Exclusion criteria :
- Squamous histology/cytology lung cancer
- Need for a major surgical procedure or radiation therapy during the study
- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
- Cumulative radiation therapy to \>25% of the total bone marrow
- History of brain metastases
- Eastern Cooperative Oncology Group(ECOG)\>1
- Prior docetaxel treatment but have not been appropriate for safety reasons
- Inadequate organ and bone marrow function
- Uncontrolled hypertension
- Evidence of clinically significant bleeding diathesis or underlying coagulopathy
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01148615
Start Date
July 1 2010
End Date
December 1 2011
Last Update
January 13 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Investigational Site Number 156001
Guangzhou, China, 510060