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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01063946
Other study ID # BEX6587
Secondary ID 2008-007824-24
Status Completed
Phase Phase 1
First received February 4, 2010
Last updated December 20, 2011
Start date January 2010
Est. completion date September 2011

Study information

Verified date December 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ombrabulin (AVE8062)
Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

Locations

Country Name City State
Belgium Sanofi-Aventis Administrative Office Brussels

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

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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