An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy

Update Il y a 5 ans
Reference: EUCTR2006-001247-64

Woman and Man

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Extract

To determine the objective response rate (ORR) (including complete response and partial response) of RAD001 10 mg po qd monotherapy in patients with advanced (unresectable or metastatic) pancreatic NETs after the failure of cytotoxic chemotherapy (stratum 1).


Inclusion criteria

  • Pancreatic neuroendocrine tumors (NET) comprise only 1-2% of all pancreatic tumors. The annual incidence is approx. 3.5 to 4 per million population. The hormones secreted by pancreatic NET depend upon the cell of origin and are physiologically involved in a network of autocrine, paracrine, endocrine and neurotransmitter communication. While hormone secretion is not observed in all cases, the “nonfunctioning” pancreatic NET tend to be more aggressive and present with symptoms of tumor bulk