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Kinase Inhibitor
Vemurafenib for Thyroid Cancer
N/A
Waitlist Available
Led By Alan L. Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants)
ECOG performance status ≤ 2 (or Karnofsky ≥60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial tests the effects of vemurafenib on thyroid cancer patients. If successful, vemurafenib could become a new treatment for thyroid cancer.
Who is the study for?
This trial is for adults with thyroid cancer of follicular origin (like papillary or follicular) that's resistant to radioactive iodine. They must be in good health otherwise, able to take oral meds, not pregnant, and willing to use contraception. People can't join if they have other cancers, recent treatments, severe illnesses that affect study participation, brain metastases, high cardiovascular risk or are unable to follow a low iodine diet.Check my eligibility
What is being tested?
The study tests the effects of vemurafenib alone or combined with radioactive iodine on thyroid cancer. It's a pilot study—meaning it's small-scale preliminary research—to see if this combo could treat thyroid cancers that don't respond well to just radioactive iodine.See study design
What are the potential side effects?
Vemurafenib may cause joint pain, rash, fatigue, hair loss and skin growths among others. Radioactive iodine treatment can lead to dry mouth/throat issues due to salivary gland damage and possibly increase the risk of new cancers long-term.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thyroid cancer is confirmed and is of the type that starts in certain cells.
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I can take care of myself but might not be able to do heavy physical work.
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My organ and bone marrow functions are normal.
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I agree to have two biopsies of my cancer taken for research.
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I can provide samples from my thyroid cancer for testing.
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I can take pills and don't have major stomach or intestine issues.
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I am 18 years old or older.
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My thyroid cancer has a BRAF mutation.
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I have at least one tumor that can be measured.
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My side effects from previous treatments are mild, except for hair loss.
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My thyroid cancer does not respond to radioactive iodine treatment.
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I have taken a pregnancy test in the last week and it was negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response
Secondary outcome measures
objective response rate (ORR)
safety
Side effects data
From 2015 Phase 3 trial • 675 Patients • NCT0100698056%
Arthralgia
48%
Alopecia
47%
Fatigue
43%
Rash
40%
Photosensitivity Reaction
39%
Nausea
37%
Diarrhoea
34%
Headache
29%
Hyperkeratosis
29%
Skin Papilloma
26%
Pruritus
24%
Dry Skin
23%
Decreased Appetite
23%
Pain In Extremity
22%
Vomiting
21%
Pyrexia
20%
Squamous cell carcinoma of skin
18%
Erythema
17%
Sunburn
16%
Dysgeusia
16%
Back Pain
15%
Asthenia
15%
Oedema Peripheral
15%
Constipation
15%
Myalgia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Abdominal Pain Upper
11%
Keratoacanthoma
11%
Nasopharyngitis
11%
Insomnia
10%
Blood Alkaline Phosphatase Increased
10%
Dyspnoea
10%
Weight Decreased
10%
Anaemia
10%
Abdominal Pain
10%
Keratosis Pilaris
10%
Palmar-Plantar Erythrodysaesthesia Syndrome
10%
Rash Maculo-Papular
9%
Blood Bilirubin Increased
9%
Influenza Like Illness
9%
Pain
9%
Paraesthesia
8%
Chest Pain
8%
Dermal Cyst
8%
Peripheral Swelling
8%
Blood Creatinine Increased
8%
Oropharyngeal Pain
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Gamma-Glutamyltransferase Increased
7%
Aspartate Aminotransferase Increased
7%
Chills
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Dermatitis Acneiform
5%
Abdominal Distension
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Dehydration
1%
Pleuritic pain
1%
Seizure
1%
Abdominal pain
1%
Thrombocytopenia
1%
Pulmonary embolism
1%
Uveitis
1%
Pancreatitis
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Chest pain
1%
Pneumonia
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Acute kidney injury
1%
Pleural effusion
1%
Blood alkaline phosphatase increased
1%
Gastrointestinal haemorrhage
1%
Bowen's disease
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vemurafenib
Vemurafenib After Crossover
Dacarbazine
Trial Design
1Treatment groups
Experimental Treatment
Group I: thyroid cancer patientsExperimental Treatment3 Interventions
Patients will have lesional dosimetry with 124I PET/CT performed to quantify the baseline iodine avidity of index metastatic lesion(s). Patients will then receive vemurafenib (960 mg orally BID) for about 4 weeks, after which a second 124I PET/CT will be performed. For patients in whom the second 124I PET/CT demonstrates that > or = 2000 cGy can be achieved in at least one tumor with < 300 mCi of 131I, Thyrogen-stimulated standard dosimetry & therapeutic 131I will be performed/administered concurrently with vemurafenib. The drug will then be discontinued & tumor assessments will be conducted with serial radiologic scan(s) & thyroglobulins (scans will be performed at baseline, before 131I, 3-4 months following 131I, & 6 months after 131I). Patients whose tumors fail to demonstrate adequate iodine incorporation following vemurafenib to warrant 131I therapy, the study drug will be discontinued, a final tumor assessment will be performed, & the patient will be taken off the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,610 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,677 Total Patients Enrolled
Alan L. Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I cannot follow a low iodine diet or need medication high in iodide.I have not had any other cancers in the past 3 years.I have brain or spinal cord cancer symptoms or untreated cancer spread.You have had a bad reaction to drugs similar to vemurafenib or thyrotropin alpha.My thyroid cancer is confirmed and is of the type that starts in certain cells.I have not recently been treated for thyroid cancer.I can take care of myself but might not be able to do heavy physical work.My organ and bone marrow functions are normal.I agree to have two biopsies of my cancer taken for research.I can provide samples from my thyroid cancer for testing.I have had a scan with iodine contrast in the last 3 months.I am unable or unwilling to follow the study's required procedures.I can take pills and don't have major stomach or intestine issues.You are expected to live for more than 3 months.I am 18 years old or older.My thyroid cancer has a BRAF mutation.I have a history of heart problems or am at risk for them.I have at least one tumor that can be measured.My side effects from previous treatments are mild, except for hair loss.My thyroid cancer does not respond to radioactive iodine treatment.I have taken a pregnancy test in the last week and it was negative.
Research Study Groups:
This trial has the following groups:- Group 1: thyroid cancer patients
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.
Is recruitment of participants still taking place for this experiment?
"This medicinal endeavour is no longer accepting any participants. It was originally made available on May 1st, 2014 with the last update being done on February 28th, 2022. Currently there are 227 active trials for patients suffering from thyroid carcinoma and 48 studies recruiting candidates that hope to be treated with Vemurafenib."
Answered by AI
In what cases is Vemurafenib typically prescribed?
"Vemurafenib is a viable therapeutic option for those who suffer from thyroid cancer, metastatic melanoma, and non-small cell lung carcinoma."
Answered by AI
How many participants are being accepted into this research trial?
"At this time, enrollment for the specified study is not available. Initially posted on May 1st 2014 and last updated on February 28th 2022, any interested participants should consider the 227 clinical trials actively recruiting those with thyroid carcinoma or one of the 48 studies utilizing Vemurafenib as a treatment option."
Answered by AI
Have researchers conducted other inquiries involving Vemurafenib?
"Currently, 48 studies are undergoing clinical trials to evaluate the efficacy of Vemurafenib with 5 Phase 3 experiments. Primarily taking place in Toronto, Ontario, 1630 medical centres worldwide have opened their doors for these investigations."
Answered by AI
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