Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
|ClinicalTrials.gov Identifier: NCT01263951|
Recruitment Status : Unknown
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : December 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Differentiated Thyroid Cancer||Drug: Everolimus Drug: Sorafenib||Phase 2|
The purpose of this research study is to:
- Find out if sorafenib and everolimus prevent the growth of tumors that have grown when treated with sorafenib alone
- Find out how long one might benefit from treatment with sorafenib and everolimus
- Find out what side effects this drug may cause
- 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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Sorafenib Alone|
|Study Start Date :||November 2010|
|Primary Completion Date :||November 2014|
Experimental: Everolimus and sorafenib
All patients will receive everolimus and sorafenib daily.
One 5 mg. tablet daily.
Other Name: AfinitorDrug: Sorafenib
200 mg. twice daily.
Other Name: Nexavar
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263951
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Marcia Brose, MD, PhD||Hospital of the University of Pennsylvania- Abramson Cancer Center|