MedTrace Logo

Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 in Patients With Solid Tumors

NCT00968916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-19

No results posted yet for this study

Summary

Primary objective: To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in patients with advanced solid tumors.

Secondary objectives:

* To assess the overall safety profile of the drug.
* To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR 258063.
* To evaluate anti-tumor activity of the drug.

Conditions

Interventions

DRUG

ombrabulin (AVE8062)

Pharmaceutical form: injection solution Route of administration: intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Japan

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00968916 on ClinicalTrials.gov