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
18 Years
N/A
Both
Neoplasms, Malignant
Trial Information
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
The duration of the study for each patient will include approximately 4 weeks of a screening
phase prior to first infusion of study drug, 21-day study treatment cycles and end of
treatment visit. The patient can continue treatment until disease progression, unacceptable
toxicity, or the patient's refusal of further treatment.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of radioactive dose excreted in urine, feces and expired air
Outcome Time Frame:
3 weeks (end of cycle 1) or 30 days after the first dose
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
BEX6587
NCT ID:
NCT01063946
Start Date:
January 2010
Completion Date:
September 2011
Related Keywords:
- Neoplasms, Malignant
- Neoplasms
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