RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms|
- 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To assess the pharmacokinetics of this combination regimen. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To allow a preliminary assessment of the anti-tumor effects of this novel drug combination. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: RAD001 in combination with figitumumab||
Taken orally once a day.Drug: CP-751,871
Given intravenously on Day 1 of a 21-day cycle
- 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 doses.
- Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Suzanne George, MD||Dana-Farber Cancer Institute|