Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
- Participants will take RAD001 by mouth daily. They will also take temozolomide by
mouth daily for one week, followed by a one-week break period. This one-week on/one
week off schedule for temozolomide will continue for the duration of the treatment.
- After the first month of treatment, there will be a 7-day observation period during
which no study medication will be taken to observe for any side effects.
- During all treatment cycles (1 cycle is 28 days in length) participants will have a
physical exam and will be asked questions about their general health and specific
questions about any problems they may be experiencing. Initially, participants will
come in every other week. At each of these visits, blood work will be taken to monitor
the participants health.
- After every 2 months of treatment, participants will have a CT scan or MRI done to see
how the medication is working.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors.
Jennifer Chan, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|