RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms

Solid Tumor Clinical Trial

Official title: Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

• 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Sarcoma
• Solid Tumor

• NCT number: NCT00927966
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 1
• Start date: July 2009
• Completion date: January 2011