Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT00942682|
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : April 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumor Carcinoid Tumor Pancreatic Neuroendocrine Tumor||Drug: Sorafenib Drug: RAD001||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Sorafenib and RAD001
Taken orally twice dailyDrug: RAD001
Taken orally once daily in the morning
- To determine the maximum tolerated dose (MTD) for sorafenib in combination with RAD001 in patients with advanced neuroendocrine tumors. [ Time Frame: 2 years ]
- To determine the dose-limiting toxicities of sorafenib combined with RAD001 in patients with advanced neuroendocrine tumors [ Time Frame: 2 years ]
- To determine the safety and tolerability of the combination of sorafenib and RAD001 in patients with advanced neuroendocrine tumors. [ Time Frame: 2 years ]
- To make a preliminary assessment of the anti-tumor activity of the combination of sorafenib and RAD001 in patients with advanced neuroendocrine tumors. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942682
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer Chan, MD, MPH||Dana-Farber Cancer Institute|