A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063946

Enrollment

Registered

2010-02-05

Start date

2010-01-31

Completion date

2011-09-30

Last updated

2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Malignant

Brief 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

Detailed 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.

Interventions

DRUGOmbrabulin (AVE8062)

Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of radioactive dose excreted in urine, feces and expired air	3 weeks (end of cycle 1) or 30 days after the first dose
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

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026