Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01263951|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : October 26, 2021
|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)|
|Actual Enrollment :||35 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|
|Actual Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Everolimus and sorafenib
All patients will receive everolimus and sorafenib daily.
One 5 mg. tablet daily.
Other Name: Afinitor
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|