Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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.