A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies
20 Years
N/A
Both
Neoplasms
Trial Information
A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- Histologically confirmed cancer patients without standard of care
- ECOG performance status 0, 1, or 2
- Adequate organ and bone marrow function
Exclusion Criteria:
- Need for a major surgery or radiation therapy during the study
- History of hypersensitivity to S-1
- Known dihydropyrimidine dehydrogenase deficiency
- Uncontrolled hypertension
- History of brain metastases
- Ascites requiring drainage
- Pregnancy or breastfeeding
- Patients who have previously been treated with AVE0005
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Outcome Time Frame:
during the first cycle of study treatment
Safety Issue:
Yes
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
TED10089
NCT ID:
NCT00479076
Start Date:
March 2007
Completion Date:
January 2011
Related Keywords:
- Neoplasms
- antineoplastic agents
- VEGF Trap
- Neoplasms
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