Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Status:
Unknown status
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Guangdong General Hospital Guangdong Provincial People's Hospital