A Phase II Study on Everolimus, an mTOR Inhibitor (Oral Formulation), With Octeotride LAR® in Adult Patients With Advanced, Non-functioning, Well-differentiated Gastrointestinal Neuroendocrine Tumours (GI NET)
Everolimus has been developed following two administration regimens: weekly and daily. Phase
I pharmacodynamic studies recommend doses of 50 mg weekly and 10 mg/daily, based on its
toxicity and inhibitory effect of the mTOR pathway in tumours; although the inhibition of
this pathway has been demonstrated, the knowledge of response prediction factors has not
been developed, in part due to the very low responses found in the population in phase I
studies. These factors can be better outlined in a phase II study, where patients who have
received fewer previous treatments can respond better, and where the profile of responders
and non-responders can be identified more easily.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients with PFS
Rate of patients
After 12 month of study treatment
No
Ramón Salazar, MD, PhD
Study Chair
Grupo Espanol de Tumores Neuroendocrinos
Spain: Spanish Agency of Medicines
GETNE 1003
NCT01567488
June 2011
March 2014
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