Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
- Participants will be receiving two study medications, SOM230 and RAD001, during each
treatment cycle. Each treatment cycle lasts 4 weeks.
- For the first four weeks of treatment, the participant will self-administer the SOM230
twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they
will switched to the long-acting SOM230 which will be administered during scheduled
treatment visits once every 4 weeks. For the first two weeks after switching to the
long-acting SOM230, participants will continue to self-administer the short-acting
SOM230 twice a day.
- RAD001 will be taken orally once every day.
- On Day 1 of every cycle, a physical exam and blood tests will be performed. Following
every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed.
- Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK
samples will be taken right before the study drug is administered and then 1, 2, 3, and
5 hours later.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population.
Jennifer Ang Chan, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|