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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 : February 3, 2021
Sponsor:
Collaborators:
Bayer
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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Brief Summary:
The goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.

Condition or disease Intervention/treatment Phase
Differentiated Thyroid Cancer Drug: Everolimus Drug: Sorafenib Phase 2

Detailed Description:

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.
Study Design
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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 : March 2021

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

Drug: Sorafenib
200 mg. twice daily.
Other Name: Nexavar


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]
  2. 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 ]
  3. To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples. [ Time Frame: Every 4 weeks ]
  4. 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 ]
  5. To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]
  6. To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Bayer
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Marcia Brose, MD, PhD Hospital of the University of Pennsylvania- Abramson Cancer Center
More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
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: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not at this time
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Differentiated metastatic thyroid cancer
Additional relevant MeSH terms:
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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