MedDataX Logo

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

NCT ID: NCT01063946

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Malignant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

[14C]-AVE8062

Single, 30 minute, intravenous infusion of 25 mg/m² of \[14C\]-AVE8062 containing 1.85 MBq (50µCi) at the first cycle, followed by subsequent administrations with non-radiolabelled AVE8062 in combination with cisplatin every 3 weeks, according to the investigator's judgment.

Group Type EXPERIMENTAL

Ombrabulin (AVE8062)

Intervention Type DRUG

Pharmaceutical form:concentrate solution

Route of administration: intravenous infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ombrabulin (AVE8062)

Pharmaceutical form:concentrate solution

Route of administration: intravenous infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis Administrative Office

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-007824-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BEX6587

Identifier Type: -

Identifier Source: org_study_id