Liver Carcinoma Clinical Trial
Official title:
Dose-finding, Safety, Pharmacokinetic and Pharmacodynamic Study of AVE1642, an Anti-Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, Administered as Single Agent and in Combination With Other Anti Cancer Therapies (Sorafenib or Erlotinib) in Patients With Advanced Liver Carcinoma
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.
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 during infusion will be implemented when needed. The duration of the
study for one patient will include a period for inclusion of up to 2 weeks, at least 2
cycles of treatment in dose escalation step (one cycle of AVE1642 alone and at least one
cycle of AVE1642 in combination) and at least one cycle of the combination in the extension
cohort, followed, when possible, by a minimum of 30-day follow-up after the last drug
administration, in order to detect any potential immunogenicity. In the second step, the
patients will continue treatment until disease progression, unacceptable toxicity or
willingness to stop.
The expected enrolment period is 15 months with at least 30 day follow-up after the last
patient treated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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