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Tyrosine Kinase Inhibitor
Regorafenib for Thyroid Cancer
Phase 2
Waitlist Available
Led By Kartik Seghal, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years.
Patients must have received at least one prior line of targeted therapy.
Must not have
Evidence or history of bleeding diathesis or coagulopathy.
Dehydration Grade ≥1 NCI-CTCAE v4.0.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying regorafenib to see how well it works in treating patients with thyroid cancer that has spread to other parts of the body and cannot be removed by surgery.
Who is the study for?
Adults with metastatic medullary thyroid cancer who've had at least one prior targeted therapy can join this study. They must be able to take oral meds, have a life expectancy of 3+ months, and agree to use contraception. Excluded are those with recent severe bleeding, certain infections like HIV or hepatitis B/C, uncontrolled high blood pressure, known allergies to the drug being tested (regorafenib), or other serious health issues.
What is being tested?
The trial is testing regorafenib as a second or third line treatment for thyroid cancer. Regorafenib is a targeted therapy designed to attack cancer cells more precisely and spare normal cells. Participants will receive this medication orally to evaluate its effectiveness against their cancer.
What are the potential side effects?
Regorafenib may cause side effects such as fatigue, hand-foot skin reactions, diarrhea, increased blood pressure, voice changes and pain in the mouth/throat area. It might also lead to liver problems or infection due to low white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have previously received treatment specifically targeting my cancer.
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My thyroid cancer has spread and was confirmed by a lab test.
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I can provide a tissue sample from my cancer for testing.
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I am fully active and can carry on all pre-disease activities without restriction.
Select...
I can swallow and keep down pills.
Select...
My cancer has worsened in the last 6 months according to scans.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of bleeding or clotting disorders.
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I am experiencing mild to severe dehydration.
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I do not have a severe ongoing infection.
Select...
I do not have any serious heart conditions.
Select...
I have brain or meningeal tumors that are causing symptoms.
Select...
I currently have symptoms of interstitial lung disease.
Select...
I have been diagnosed with pheochromocytoma.
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I have severe protein in my urine.
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I have not had radiation in the last 14 days and do not need dialysis.
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I have a condition that affects how my body absorbs nutrients.
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I am not receiving any cancer treatments other than the study treatment.
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I am on blood thinners like warfarin or heparin.
Select...
I am currently using herbal remedies like St. John's Wort.
Select...
I have HIV or hepatitis B/C that needs antiviral treatment.
Select...
I have previously taken regorafenib.
Select...
My high blood pressure is not controlled even with medication.
Select...
I haven't taken any tyrosine kinase inhibitors recently.
Select...
I have a non-healing wound or fracture not caused by cancer.
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I have not had severe bleeding in the last 4 weeks.
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I have had an organ transplant.
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I have been treated with regorafenib before.
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I am not pregnant or breast-feeding.
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I have fluid in my chest or abdomen causing significant breathing problems.
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I am on medication for seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
10-month Progression-free Survival (PFS) Rate [MTC Cohort]
Response Rate [Differentiated Thyroid Cancer (DTC)] DATA NOT MATURE YET
Secondary study objectives
Grade 3-5 Treatment-related Toxicity Rate [MTC Cohort]
Quality of Life (QOL) DATA NOT MATURE YET
Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
Large intestine perforation
1%
Oesophagitis
1%
Lung abscess
1%
embolism
1%
pancreatic carcinoma
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RegorafenibExperimental Treatment1 Intervention
Regorafenib tablets 80mg orally, once daily at predetermined dosage for 21 days per cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1600
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,203 Total Patients Enrolled
BayerIndustry Sponsor
2,275 Previous Clinical Trials
25,539,391 Total Patients Enrolled
Kartik Seghal, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of bleeding or clotting disorders.I am 18 years old or older.I am experiencing mild to severe dehydration.I do not have a severe ongoing infection.I do not have any serious heart conditions.I have no other cancers except for treated skin, superficial bladder cancer, or in-situ cervical cancer.I have brain or meningeal tumors that are causing symptoms.I currently have symptoms of interstitial lung disease.I have been diagnosed with pheochromocytoma.I have severe protein in my urine.I have previously received treatment specifically targeting my cancer.I have not had radiation in the last 14 days and do not need dialysis.I have a condition that affects how my body absorbs nutrients.I am not receiving any cancer treatments other than the study treatment.I am on blood thinners like warfarin or heparin.I am currently using herbal remedies like St. John's Wort.My thyroid cancer has spread and was confirmed by a lab test.I can provide a tissue sample from my cancer for testing.My recent tests show my bone marrow, liver, and kidneys are functioning well.I am not pregnant or incapable of becoming pregnant.I have HIV or hepatitis B/C that needs antiviral treatment.I have previously taken regorafenib.My high blood pressure is not controlled even with medication.I haven't had major surgery or a serious injury in the last 28 days.I am fully active and can carry on all pre-disease activities without restriction.I haven't taken any tyrosine kinase inhibitors recently.I have a non-healing wound or fracture not caused by cancer.I have had previous chemotherapy or targeted therapy treatments.I have not had severe bleeding in the last 4 weeks.I have had an organ transplant.I have been treated with regorafenib before.I am not pregnant or breast-feeding.I can swallow and keep down pills.I haven't had major surgery or a serious injury in the last 28 days.I agree to use birth control from the start of the study until 2 months after the last dose.You must have at least one area of the body where the disease can be accurately measured according to specific guidelines.My cancer has worsened in the last 6 months according to scans.I have fluid in my chest or abdomen causing significant breathing problems.I haven't had a stroke, clot, or embolism in the last 6 months.I am on medication for seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib
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.
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