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Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

Primary Purpose

Differentiated Thyroid Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Everolimus

Sorafenib

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer focused on measuring Differentiated metastatic thyroid cancer

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus and sorafenib

Arm Description

All patients will receive everolimus and sorafenib daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.

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.

To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples.

To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures.

To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib.

To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib.

Full Information

NCT ID

NCT01263951

First Posted

November 29, 2010

Last Updated

October 18, 2021

Sponsor

Thomas Jefferson University

Collaborators

Bayer, Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01263951

Brief Title

Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

Bayer, Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Differentiated Thyroid Cancer

Keywords

Differentiated metastatic thyroid cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Everolimus and sorafenib

Arm Type

Experimental

Arm Description

All patients will receive everolimus and sorafenib daily.

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Afinitor

Intervention Description

One 5 mg. tablet daily.

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Other Intervention Name(s)

Nexavar

Intervention Description

200 mg. twice daily.

Primary Outcome Measure Information:

Title

Time Frame

Every 4 weeks

Secondary Outcome Measure Information:

Title

To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.

Time Frame

Every 4 weeks

Title

Time Frame

Every 4 weeks

Title

To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples.

Time Frame

Every 4 weeks

Title

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

Title

To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib.

Time Frame

Every 4 weeks

Title

To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib.

Time Frame

Every 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcia Brose, MD, PhD

Organizational Affiliation

Hospital of the University of Pennsylvania- Abramson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not at this time

Learn more about this trial

Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

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