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Kinase Inhibitor
Sorafenib for Medullary Thyroid Cancer
Phase 2
Waitlist Available
Led By Bhavana Konda
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ELIGIBILITY CRITERIA COMMON FOR ARMS A AND B: Patients must have measurable disease
ELIGIBILITY CRITERIA COMMON FOR ARMS A AND B: Patients must have an Eastern Cooperative Oncology Group performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks after last dose of sorafenib tosylate
Awards & highlights
Study Summary
This trial looks at how well a drug called sorafenib tosylate works in treating patients with thyroid cancer that has spread or returned. The drug may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who is the study for?
This trial is for patients with advanced or recurrent medullary thyroid cancer. Participants must have measurable disease, be in relatively good health (ECOG status 0-2), and have a life expectancy of at least six months. They should not be pregnant, must agree to use contraception, and cannot have had recent anti-tumor therapy or radiation. People allergic to sorafenib or those with certain medical conditions that could interfere with the drug are excluded.Check my eligibility
What is being tested?
The trial is testing Sorafenib Tosylate's effectiveness on metastatic, locally advanced, or recurrent medullary thyroid cancer. It aims to see if this drug can stop tumor growth by inhibiting enzymes needed for cell proliferation and cutting off blood supply to tumors.See study design
What are the potential side effects?
Sorafenib Tosylate may cause side effects such as rash, diarrhea, fatigue, and hand-foot skin reactions. It might also lead to high blood pressure and affect liver function. The severity of these side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with medullary thyroid carcinoma as part of an inherited condition like multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks after last dose of sorafenib tosylate
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks after last dose of sorafenib tosylate
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer
Secondary outcome measures
Degree of Ras-MAPK Signaling Inhibition in the Tumor
Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor
Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor
+6 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib tosylate)Experimental Treatment1 Intervention
Patients receive sorafenib tosylate PO BID in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib Tosylate
2005
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,468 Total Patients Enrolled
13 Trials studying Thyroid Gland Medullary Carcinoma
634 Patients Enrolled for Thyroid Gland Medullary Carcinoma
Bhavana KondaPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any signs of a bleeding disorder.Your liver function tests should be within a certain range 10 days before you join the study.Your kidney function is normal or your kidneys are able to filter out waste products effectively.You have been diagnosed with medullary thyroid carcinoma, and it is not related to any inherited condition.You are currently using other treatments for thyroid cancer or taking part in a research study for a different type of cancer. If you are taking hormonal therapy for another cancer, you can join the study as long as there are no known interactions with the study drug.You have been diagnosed with medullary thyroid carcinoma as part of an inherited condition like multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC).Pregnant women or women who are breastfeeding cannot take part in this study because the potential risks to the baby from the study drug have not been evaluated. If a mother is treated with the study drug, she should stop breastfeeding.You have cancer that has spread to other parts of the body or is at an advanced stage.Your white blood cell count is at least 2,000 cells per microliter within 10 days before joining the study.Your total bilirubin level must be within a certain range, as measured within the 10 days before you join the study.If you have cancer that has spread to your bones, and you are taking certain medications for it, you can still participate in the study. The doctor will decide if it's okay for you to continue taking these medications during the study.You are currently taking medication to prevent blood clots for a medical reason, except for low-dose warfarin or if you have a device to access your veins or arteries, as long as your blood clotting tests are normal.Your white blood cell count must be at least 1,000 per microliter.You have HIV and are taking certain medications for it, or you have a weak immune system, which can increase the risk of serious infections when receiving treatment with sorafenib.You are taking certain medications for epilepsy or other conditions that could interact with the study drug.You had an allergic reaction to a medicine similar to sorafenib in the past.You cannot have had external beam radiation therapy within the past week, or if the side effects from the radiation are not mostly resolved before joining the study.You need to have at least 100,000 platelets per microliter of blood 10 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sorafenib tosylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other studies has Sorafenib Tosylate been a part of?
"The first Sorafenib Tosylate trial was completed in 2005 at Central Illinois Hematology Oncology Center. 396 trials have been completed in total. As of right now, there are 65 active studies taking place with many of them in Saint Louis, Missouri."
Answered by AI
What side effects could a person expect when taking Sorafenib Tosylate?
"At the moment, there is not enough data to support the efficacy of Sorafenib Tosylate. However, Phase 2 trials have some evidence suggesting that it is safe. Therefore, our team rates its safety at a 2."
Answered by AI
How is Sorafenib Tosylate most commonly employed?
"Progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc) is commonly treated with Sorafenib Tosylate. Sorafenib Tosylate is also effective at treating other conditions including gastrointestinal stromal tumors, hemangiosarcoma, and leiomyosarcoma."
Answered by AI
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