Neoplasms, Malignant Clinical Trial
Official title:
A Phase I, Open Label Study Investigating the Disposition of 25 mg/m² [14C]-AVE8062 (1.85 MBq, 50 µCi) Administered at Cycle 1 as a 30-minute Intravenous Infusion to Patients With Advanced Solid Tumors
Primary Objectives:
- To determine the excretion balance and systemic exposure of radioactivity after
intravenous infusion of [14C]-AVE8062 to humans
- To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to
overall exposure
- To collect samples to determine the metabolic pathways of AVE8062 and identify the
chemical structures of the main metabolites
Secondary Objective:
- To assess the safety profile of the drug
Status | Completed |
Enrollment | 3 |
Est. completion date | September 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists. - Age = or > 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Adequate hematological, hepatic and renal functions Exclusion criteria: - Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Sanofi-Aventis Administrative Office | Brussels |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of radioactive dose excreted in urine, feces and expired air | 3 weeks (end of cycle 1) or 30 days after the first dose | No | |
Primary | Concentration-time profiles and pharmacokinetic (PK) parameters of total radioactivity in whole blood and plasma; blood over plasma concentration ratios; Concentration-time profile and PK parameters of AVE8062 and RPR258063 in plasma | 3 weeks (end of cycle 1) or 30 days after the first dose | No | |
Secondary | Safety assessment based on Adverse events reporting, laboratory tests according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) v3.0 grade scaling | 3 weeks (end of cycle 1) or 30 days after the first dose | Yes |
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