At a glance
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A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
In Brief
A Phase 2 clinical trial evaluating RAD001 (everolimus, Afinitor®) for Neuroendocrine Tumors and Carcinoid Tumor. Targeting 20 participants across 1 site.
Detailed Summary
RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: * directly on the tumor cells by inhibiting tumor cell growth and proliferation * indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
Study Details
Timeline
Interventions
RAD001 will be provided by Novartis to the study sites. RAD001 is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 30 tablets. The study site will dispense an adequate supply of RAD001 to the patient for self-administration at home. 2 x 5 mg (=10 mg) RAD001 p.o., once daily, at the same time each day, One treatment cycle consists of 28 days.