A Phase II Trial Using RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
- RAD001 will be taken once a day in the morning starting on Day 1 and continue until the
participant is no longer participating in the study treatment.
- A history and physical exam will be performed the first day of the study and then once
a month. Blood tests including coagulation studies, and thyroid studies will be
performed monthly. A urine sample will need to be provided on the first day of
treatment and then every 2 months. Imaging consisting of a CT or MRI of the neck,
chest and abdomen will be done every 8 weeks after starting RAD001.
- Participants will remain on this research study for up to 24 months. However, if the
participants doctor feels that they are benefiting from the study drug and they do not
have severe side effects, they may be given the option to continue taking RAD001.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
2 years
No
Jochen Lorch, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
09-049
NCT00936858
July 2009
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Mt. Sinai Medical Center | New York, New York 10029 |