Status unknownNCT01263951Updated Oct 26, 2021

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

A Phase 2 interventional study of Everolimus and Sorafenib in Differentiated Thyroid Cancer, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Thomas Jefferson University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 35
Allocation: Not applicable
Ages: 18 Years to 89 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Differentiated Thyroid Cancer

Browse trials for

Keywords

Differentiated metastatic thyroid cancer

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 35 is below the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 89 Years
Sexes eligible: 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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

Experimental
Everolimus and sorafenib
All patients will receive everolimus and sorafenib daily.
Drug: Everolimus · Drug: Sorafenib

Interventions

DrugEverolimus
One 5 mg. tablet daily.
Also known as: Afinitor
DrugSorafenib
200 mg. twice daily.
Also known as: Nexavar

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

References and documents

Individual participant data

Plan to share: No — Not at this time

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01263951
Lead sponsor: Thomas Jefferson University
Collaborators: Bayer, Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Dec 21, 2010
Start date: Nov 2010
Primary completion: Feb 1, 2021
Completion: May 2022 (estimated)
Last update: Oct 26, 2021

Study contacts

Marcia Brose, MD, PhD

principal investigator · Hospital of the University of Pennsylvania- Abramson Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thyroid Neoplasms→

Other studies from this sponsor

Thomas Jefferson University

Start the discussion