Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms
- In this research study, each "cycle" of study drug dosing lasts 21 days. In the first
cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2
through 4, participants will come to the clinic on Days 1 and 8. The rest of the
clinic visits will occur on Day 1 of every cycle thereafter.
- During each cycle, participants will take RAD001 orally, once a day in the morning. In
addition, participants will receive CP-751,871 intravenously once every cycle on the
first day of each cycle.
- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects, not everyone who participates in
this research study will receive the same dose of the study drug. The dose will depend
on the number of participants enrolled in the study and how well they tolerated their
- Participants may remain on this research study as long as they do not have serious side
effects or their diseae does not get worse.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.
Suzanne George, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|