Differentiated Thyroid CancerPhase 2NCT01263951
Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
A Phase 2 study testing Everolimus and Sorafenib in people with Differentiated Thyroid Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Everolimus and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Sorafenib Alone
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
- Differentiated Thyroid Cancer
- Being tested
- Everolimus, Sorafenib
- Keywords
- Differentiated metastatic thyroid cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Afinitor
One 5 mg. tablet daily.
SorafenibDrug
Also called Nexavar
200 mg. twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus and sorafenib | Experimental | All patients will receive everolimus and sorafenib daily. Receives: Drug: Everolimus; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 4 weeks
Secondary outcomes (6)
To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.
Measured: 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.
Measured: Every 4 weeks
To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples.
Measured: Every 4 weeks
To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures.
Measured: Every 4 weeks
To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib.
Measured: Every 4 weeks
To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib.
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startNov 2010
- Primary completion1 Feb 2021
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Marcia Brose, MD, PhD, Principal investigator, Hospital of the University of Pennsylvania- Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263951
- Sponsor's protocol ID
- UPCC 19309
- Other IDs
- 812004
- Status last verified
- Oct 2021
- First submitted
- 29 Nov 2010
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Not at this time
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Sorafenib Alone
- ClinicalTrials.gov ID
- NCT01263951
- Acronym / sponsor ID
- UPCC 19309
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated metastatic thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bayer, Novartis Pharmaceuticals
- Study start
- Nov 2010
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus and sorafenib | Experimental | Drug: Everolimus, Drug: SorafenibAll patients will receive everolimus and sorafenib daily. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: AfinitorOne 5 mg. tablet daily. | Drug | Everolimus and sorafenib |
| SorafenibAlso: Nexavar200 mg. twice daily. | Drug | Everolimus and sorafenib |
Primary outcome
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
6 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No. Not at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Brose, MD, PhD principal investigator
Hospital of the University of Pennsylvania- Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus and Sorafenib in people with Differentiated Thyroid Cancer, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.