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A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Sorafenib Alone

Phase 2
18 Years
89 Years
Open (Enrolling)
Differentiated Thyroid Cancer

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Trial Information

A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have 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.

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)

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Every 4 weeks

Safety Issue:


Principal Investigator

Marcia Brose, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital of the University of Pennsylvania- Abramson Cancer Center


United States: Food and Drug Administration

Study ID:

UPCC 19309



Start Date:

November 2010

Completion Date:

January 2012

Related Keywords:

  • Differentiated Thyroid Cancer
  • Differentiated metastatic thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases



Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104