Dose Escalation Study of RAD001 in Combination w/Chemotherapy & Radiation in Patients With NSCLC
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | June 2012 |
A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC
The purpose of this study is to understand the effects (good and/or bad) of the addition of
RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with
non-small cell lung cancer.
In oncology, clinical experience with RAD001 has been based on a number of phase I and II
studies with single agent RAD001 as well as phase Ib and II studies of RAD001 in combination
with other chemotherapeutic and molecular targeted agents, including paclitaxel,
gemcitabine, and erlotinib among others. More recently, a phase III trial of single agent
RAD001 in patients with metastatic renal cell carcinoma who had failed therapy with VEGF
tyrosine kinase inhibitors was completed. Clinical experience for indications other than
oncology comes from single dose studies in healthy volunteers, and studies in solid organ
transplant patients, where RAD001 was administered with other immunosuppressive agents.
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