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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities (DLT) based on grade = or > 3 hematological or non-hematological toxicity and on fasting hyperglycemia
Cycle 1 and cycle 2 (6 weeks)
Yes
Olivier Rosmorduc, Professor
Principal Investigator
Hôpital St Antoine, 184 rue du Faubourg St Antoine, 75012 Paris - France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
TED10630
NCT00791544
November 2008
November 2009
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