Status:
TERMINATED
Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma
Lead Sponsor:
Sanofi
Conditions:
Liver Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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: *...
Detailed Description
AVE1642 will be administered as an IV infusion on day 1 and then every 3 weeks for at least 2 infusions for evaluability requirements. Curative and / or prophylactic management of allergic reactions d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00791544
Start Date
November 1 2008
End Date
November 1 2009
Last Update
August 4 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France