Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer
|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: NCT01141309|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2010
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: sorafenib with everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer|
|Actual Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: sorafenib with everolimus
This is a two-stage phase II study combining sorafenib with everolimus in patients with thyroid cancer.
Drug: sorafenib with everolimus
Treatment will be with sorafenib 400 mg orally twice a day and everolimus 5 mg orally daily. Restage every 2 cycles *Cycle = 4 weeks of treatment.
Subjects may consent to allowing blood to be drawn for DNA. Two blue top tubes will be required. Approximately 5-6 ml will be needed. This may be done at anytime, including before, during, or after treatment. This is not required to participate in the study.
- Determine the response rate of the combination sorafenib and everolimus. [ Time Frame: 16 weeks ]
- Evaluate if mutations in the pTEN, PI3K AKT, mTOR pathway, predict response to therapy. [ Time Frame: done prior to the start of therapy and again 3-5 weeks after the start of treatment ]
- Determine the progression free survival under the combination of sorafenib and everolimus. [ Time Frame: 2 years ]
- Assess safety and toxicity. [ Time Frame: once a week ]This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.
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): NCT01141309
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Eric Sherman, MD||Memorial Sloan Kettering Cancer Center|