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Kinase Inhibitor

Sorafenib + Everolimus for Thyroid Cancer

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
No prior use of sorafenib or an mammalian target of rapamycin (mTOR) inhibitor for the treatment of thyroid cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether adding everolimus to sorafenib tosylate helps treat patients with radioactive iodine refractory thyroid cancer better than sorafenib tosylate alone.

Who is the study for?
Adults with advanced Hurthle cell thyroid cancer that hasn't responded to radioactive iodine treatment can join. They should have measurable disease, no recent major surgery, and their blood counts and liver function need to be within certain limits. No prior sorafenib or mTOR inhibitors for thyroid cancer, no brain metastasis, and a good performance status are required.Check my eligibility
What is being tested?
The trial is testing if adding everolimus to sorafenib tosylate improves outcomes in patients with this type of thyroid cancer. Participants will either receive both drugs or only sorafenib tosylate, randomly assigned, to see which approach is more effective at stopping tumor growth.See study design
What are the potential side effects?
Possible side effects include increased risk of infections due to immune system suppression, high cholesterol levels, digestive issues like fistulas or perforations, liver problems, bleeding complications if on anticoagulants (blood thinners), heart issues such as myocardial infarction or angina.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have never used sorafenib or mTOR inhibitors for thyroid cancer.
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I have never had cancer spread to my brain.
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My thyroid cancer has been confirmed to be Hürthle cell type.
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I can take care of myself but might not be able to do heavy physical work.
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I can provide 10 slides or a tumor block of my thyroid for review.
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My cancer has spread or cannot be removed by surgery.
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I had chemotherapy more than 28 days ago.
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I have received multiple treatments for my condition.
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I had radiation therapy over 28 days ago and my cancer has grown since then.
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I have not had major surgery in the last 4 weeks.
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My kidney function is normal or only slightly reduced.
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I had RAI therapy over 90 days ago and my condition has worsened since.
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I had radiation therapy on areas other than the main tumor site more than 28 days ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Confirmed Response Rate
Number of Participants With Grade 3 or Higher Adverse Events
Overall Survival

Side effects data

From 2015 Phase 2 trial • 25 Patients • NCT01189370
76%
fatigue
72%
Diarrhea
68%
Nausea
60%
Hand and foot syndrome
56%
Anorexia
52%
constipation
40%
Vomiting
40%
Alopecia
40%
Rash
36%
Dermatology/Skin - Other (Specify)
36%
Pain in extremity
36%
Dyspnea
28%
Abdominal pain
28%
Acne
28%
Mucositis oral
24%
Back Pain
24%
Dry skin
24%
Taste alteration
20%
Joint pain
20%
Muscle weakness
20%
Oral pain
20%
Weight loss
20%
Edema limbs
20%
Hemoglobin
16%
Pruritis
12%
Flushing
12%
headache
12%
Infection
12%
Abdominal distention
12%
Chest pain
12%
cough
12%
Myalgia
12%
Hemorrhage nasal
12%
Hemorrhoids
12%
Sweating
8%
Esophogeal mucositis
8%
Pharyngolaryngeal pain
8%
Hypotension
8%
Voice alteration
8%
Dizziness
8%
Bruising
8%
Depression
8%
Pain - Other
8%
Peripheral sensory neuropathy
8%
dry mouth
8%
Dyspepsia
8%
Edema: head and neck
8%
Pain: scalp
8%
Skin infection
8%
Pain: stomach
4%
fever
4%
fracture
4%
Pain
4%
Gingival infection
4%
Gingival pain
4%
Vaginal infection
4%
Hypertension
4%
Vaginal discharge
4%
Vaginitis
4%
Valvular heart disease
4%
Dehydration
4%
Pain: external ear
4%
Disease progression
4%
Esophagitis
4%
Edema: trunk/genital
4%
Syncope
4%
Pelvic pain
4%
Treatment related secondary malignancy
4%
Anxiety
4%
Arthritis
4%
Ataxia
4%
Atrial fibrillation
4%
Insomnia
4%
Rectal hemorrhage
4%
Renal failure
4%
Rhinitis
4%
Rigors/chills
4%
Peripheral motor neuropathy
4%
Pneumonia
4%
Bronchitis
4%
Bronchopulmonary hemorrhage
4%
decubitus
4%
dehydration
4%
joint-function
4%
Lipase increased
4%
Musculoskeletal - Other (Specify)
4%
Nasal congestion
4%
Neutrophils
4%
Otitis, external
4%
Pain: skin
4%
Pain: pelvic
4%
Platelets
4%
Pneumonitis
4%
Psychosis
4%
Pulmonary - Other(specify)
4%
Intra-operative injury - Joint
4%
Intraoperative musculoskeletal injury
4%
Dysphagia
4%
Ear, nose and throat examination abnormal
4%
Hearing (without monitoring program)
4%
Hemorrhage urinary tract
4%
Sinus tachycardia
4%
Speech impairment
4%
Thrombosis
4%
Tooth disorder
4%
toothache
4%
Upper aerodigestive tract infection
4%
Upper respiratory infection
4%
Urinary frequency
4%
Weight gain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sorafenib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: sorafenib and everolimusExperimental Treatment2 Interventions
Patients receive sorafenib 400 mg PO twice daily and everolimus 5 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: sorafenibActive Control1 Intervention
Patients receive sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over and receive everolimus 10 mg PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
everolimus
2005
Completed Phase 3
~1550
sorafenib
2016
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,599 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,913,449 Total Patients Enrolled
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,756 Total Patients Enrolled

Media Library

Sorafenib Tosylate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02143726 — Phase 2
Thyroid Cancer Research Study Groups: sorafenib, sorafenib and everolimus
Thyroid Cancer Clinical Trial 2023: Sorafenib Tosylate Highlights & Side Effects. Trial Name: NCT02143726 — Phase 2
Sorafenib Tosylate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02143726 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple research centers participating in this trial across North America?

"This medical trial is presently offered at 21 sites, including New york City, Columbus and Goldsboro. To minimize travel requirements for participants, it is essential to select the most proximate location available."

Answered by AI

Has the FDA sanctioned sorafenib for clinical use?

"Due to the lack of clinical evidence displaying sorafenib's efficacy and some data indicating its safety, it was given a score of 2."

Answered by AI

Are individuals currently signing up to be part of this scientific experiment?

"Currently, this clinical trial is not enrolling patients. Initially posted on October 1st 2014 and most recently updated on March 11th 2022, those who are looking for alternative trials can explore the 226 studies actively recruiting participants with thyroid adenomas or 147 investigations that require sorafenib intake."

Answered by AI

What similar experiments have been completed using sorafenib?

"At present, there are 147 studies underway concerning sorafenib with 37 of them in their third stage. The majority of these clinical trials for the drug take place in Taibei, Taiwan; however, it is being tested at 6596 different facilities globally."

Answered by AI

In what circumstances is sorafenib typically prescribed?

"Sorafenib is frequently prescribed to mitigate the risk of kidney transplant rejection, but also has effectiveness in treating hemangiosarcoma, waldenstrom macroglobulinemia and certain lung conditions."

Answered by AI

How many people are currently engaged in this test?

"Recruitment for this clinical trial has been terminated. It was initially advertised on 10/1/2014 and the information was last modified 3/11/2022. Should you be seeking other studies, there are 226 trials currently accepting participants with thyroid adenoma and 147 trials recruiting patients who need sorafenib treatments."

Answered by AI
~3 spots leftby Mar 2025