Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
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ClinicalTrials.gov Identifier: NCT01263951 |
Recruitment Status :
Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : October 26, 2021
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Everolimus and sorafenib
All patients will receive everolimus and sorafenib daily.
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Drug: Everolimus
One 5 mg. tablet daily.
Other Name: Afinitor Drug: 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of thyroid cancer, that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- All patients will have been required to have had sorafenib for entry and have had documented progression while on previous treatment with sorafenib.
- Measurable disease defined as at least one malignant lesion that can be accurately measured on computerized tomography (CT) and/or magnetic resonance imaging (MRI) scan.
- ECOG performance status < 2.
- Life expectancy greater than 3 months.
- Intellectual, emotional, and physical ability to comply with oral medication.
Exclusion Criteria:
- Restrictions regarding certain prior treatments will apply.
- Significant medical disease including: uncontrolled congestive heart failure; active symptoms of coronary artery disease, uncontrolled seizure disorder; active infection; uncontrolled diabetes mellitus; requirement for chronic high dose corticosteroid treatment (Topical or inhaled corticosteroids are allowed); requirement for concurrent immunosuppressive drug(s); active autoimmune disease.
- Organ allografts.
- Known HIV-infection (HIV testing is not required for participation).
- Pregnant or breast feeding. Women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment
- History of second cancer (except adequately treated basal cell or squamous cell skin cancer, in situ treated cervical cancer, colon cancer or melanoma, or any other cancer for which the patient has been disease-free for three or more years).
- Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
- Use of any experimental therapy within 4 weeks prior to baseline evaluations done prior to enrollment (with the exception of sorafenib which may be continued until treatment start). Therefore, all experimental treatments other than sorafenib must be discontinued 4 weeks prior to baseline studies or enrollment.
- Patients who did not previously tolerate sorafenib at 200 mg once daily are excluded from the study.

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 |
Responsible Party: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT01263951 |
Other Study ID Numbers: |
UPCC 19309 812004 ( Other Identifier: University of Pennsylvania IRB #1 ) |
First Posted: | December 21, 2010 Key Record Dates |
Last Update Posted: | October 26, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Not at this time |
Differentiated metastatic thyroid cancer |
Sorafenib Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |