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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Antibodies, Monoclonal; Erlotinib Hydrochloride; Sorafenib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• ECOG performance status > 2

• Inadequate organ function:

• Neutrophils (ANC) < 1,500/mm3

• Hemoglobin < 10g/dl

• Platelets < 100,000/mm3

• Total bilirubin > 1.5 x ULN

• ASAT, ALAT > 3 x ULN

• Creatininemia > 1.5 x ULN (or ≥ 2.0 mg/dl)

• INR > 1.6

• Liver cirrhosis Child Pugh B or C (score > 6)

• HbA1C > 8%

• No measurable or evaluable tumoral lesion

• Patients not eligible for sorafenib therapy and for whom this therapy cannot be postponed by 3 weeks (during AVE1642 single treatment period) in dose escalation part

• Prior exposure to an anti-IGF-1R class compound

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.