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Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma

NCT00791544 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2010-08-04

No results posted yet for this study

Summary

The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment.

The secondary objectives of the study are:

* To evaluate the safety profile of AVE1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity.
* To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or any PK interactions when given in combination with other anti-cancer therapies.
* To assess the preliminary clinical activity in terms of response rate (Complete response + Partial response), duration of responses, stabilisation rate and duration of stabilisation, according to RECIST criteria.
* To assess the biological activity at the tumor level.

Conditions

  • Liver Carcinoma

Interventions

DRUG

AVE1642

intravenous infusion

DRUG

sorafenib

oral intake

DRUG

erlotinib

oral intake

Sponsors & Collaborators

Principal Investigators

  • Olivier Rosmorduc, Professor · Hôpital St Antoine, 184 rue du Faubourg St Antoine, 75012 Paris - France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
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 NCT00791544 on ClinicalTrials.gov