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

NCT01907685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-07-25

No results posted yet for this study

Summary

Primary Objective:

To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 \& D2 respectively every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

* To define the overall safety profile of the combination.
* To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination.
* To evaluate anti-tumor activity of the combination.
* To evaluate potential predictive biomarkers.

The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel.

Conditions

  • Advanced Neoplastic Disease

Interventions

DRUG

AVE8062

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

DRUG

Docetaxel

Pharmaceutical form: solution for infusion Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-02-28
Completion
2011-02-28

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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 NCT01907685 on ClinicalTrials.gov