Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET
Status:
Completed
Trial end date:
2017-06-07
Target enrollment:
Participant gender:
Summary
The underlying hypothesis of the synergistic activity of octreotide and everolimus is based
on the combination of a) a direct action of everolimus over mTOR (mammalian target of
rapamycin), and b) the inhibitory effect of octreotide on the IGF-I (insulin like growth
factor 1) system preventing the activation of the mTOR system by this factor. Both types of
inhibition would completely cancel this signal transduction pathway, which is so important in
neuroendocrine tumours.
Furthermore, the biological study proposed in this protocol will allow for better
establishing the relationship between the activation of the IGFR-PI3K-mTOR signal
transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response; this
information is relevant since the IGFR-PI3K-mTOR activation status could be a response
prediction factor.
This study will provide significant additional information about the efficacy of the
combination treatment of everolimus with octreotide LAR® in non-functioning GI NET.