NCT00942682

Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

Phase I Study of Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out more about the combination of RAD001 and sorafenib such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating neuroendocrine tumors.

Detailed description

* Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have neuroendocrine tumors, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant will be given will depend on the number of participants who have been enrolled in the study. * Each treatment cycle lasts 28 days. Participants will take RAD001 orally once a day in the morning. Participants will take sorafenib orally twice daily. * Initially participants will come to the clinic every other week. At these visits bloodwork will be taken to monitor the participants health. Every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working. * Participants will remain on this research study as long as they continue to benefit from the study medications.

Conditions

• Neuroendocrine Tumor
• Carcinoid Tumor
• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Sorafenib	Taken orally twice daily
DRUG	RAD001	Taken orally once daily in the morning

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-07-21
• Last updated: 2014-04-29

Locations

1 site across 1 country: United States