Trials Sponsors Conditions Drugs Pricing

Conditions

Liver Carcinoma

Keywords

monoclonal antibody, anti IGF1R

Outcome Measures

Primary Outcomes (1)

Dose-limiting toxicities (DLT) based on grade = or > 3 hematological or non-hematological toxicity and on fasting hyperglycemia
Cycle 1 and cycle 2 (6 weeks)

Secondary Outcomes (1)

Anti tumoral activity
Every 2 cycles

Study Arms (8)

Dose Level -1

EXPERIMENTAL

0.5 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2

Drug: AVE1642Drug: sorafenib

Dose Level 1

EXPERIMENTAL

1 mg/kg AVE1642 single agent at cycle 1 with sorafenib at cycle 2

Drug: AVE1642Drug: sorafenib

Dose Level 2

EXPERIMENTAL

Interventions

AVE1642Drug

intravenous infusion

Combination cohort 1Combination cohort 2Dose Level -1Dose Level 1Dose Level 2Dose Level 3Dose Level 4Dose Level 5

sorafenib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients not eligible for surgical resection, liver transplantation, local ablation techniques or chemoembolisation and with histologically proven liver carcinoma whenever possible or combination of radiologically documented hypervascular liver tumour and α foeto protein level ≥ 400 ng/ml
Signed and dated approved patient informed consent form prior to enrollment into the study

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

AVE1642SorafenibErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

Olivier Rosmorduc, Professor
Hôpital St Antoine, 184 rue du Faubourg St Antoine, 75012 Paris - France
PRINCIPAL INVESTIGATOR

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

November 2008

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (8)

Dose Level -1

Dose Level 1

Dose Level 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Dose Level 3

Dose Level 4

Dose Level 5

Combination cohort 1

Combination cohort 2

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations