Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | — | Oral |
| Subject | Sorafenib | Small molecule | — | Oral |
| Subject | Veligrotug | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | Veligrotug | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Veligrotug | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Veligrotug | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Veligrotug | Monoclonal antibody | 12 mg/kg | Intravenous |
| Subject | Veligrotug | Monoclonal antibody | 18 mg/kg | Intravenous |