The goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.
The purpose of this research study is to: 1. Find out if sorafenib and everolimus prevent the growth of tumors that have grown when treated with sorafenib alone 2. Find out how long one might benefit from treatment with sorafenib and everolimus 3. Find out what side effects this drug may cause 4. Measure the amount of sorafenib and everolimus in the blood and see if "markers" can be found to help understand who might benefit from sorafenib and everolimus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
One 5 mg. tablet daily.
200 mg. twice daily.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
To determine the efficacy of everolimus and sorafenib (progression free survival, objective response rate and stable disease) in patients with advanced differentiated thyroid cancer who have progressed on sorafenib alone.
Time frame: Every 4 weeks
To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.
Time frame: Every 4 weeks
To perform correlative scientific studies to determine the relationship between clinical response to everolimus and sorafenib and multiple parameters including the mutational status of BRAF, N-RAS and other relevant cancer genes in the tumor.
Time frame: Every 4 weeks
To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples.
Time frame: Every 4 weeks
To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures.
Time frame: Every 4 weeks
To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib.
Time frame: Every 4 weeks
To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib.
Time frame: Every 4 weeks
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