RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
|ClinicalTrials.gov Identifier: NCT00927966|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : November 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Solid Tumor||Drug: RAD001 Drug: CP-751,871||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms|
|Study Start Date :||July 2009|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
|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
- 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 ]
- To assess the pharmacokinetics of this combination regimen. [ Time Frame: 3 years ]
- To allow a preliminary assessment of the anti-tumor effects of this novel drug combination. [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927966
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Suzanne George, MD||Dana-Farber Cancer Institute|