Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
NCT00804336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2016-10-19
Summary
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.
Conditions
- Neuroendocrine Tumor
- Carcinoid Tumor
- Pancreatic Neuroendocrine Tumor
Interventions
- DRUG
-
SOM230
Given subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter
- DRUG
-
RAD001
Given orally once a day
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
Massachusetts General Hospital
collaborator OTHER - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Jennifer Ang Chan, MD, MPH · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2014-09-30
- Completion
- 2015-04-30
Countries
- United States
Study Locations
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