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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%)

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I cannot follow a low iodine diet or need medication high in iodide.

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I have not had any other cancers in the past 3 years.

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I have brain or spinal cord cancer symptoms or untreated cancer spread.

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I am unable or unwilling to follow the study's required procedures.

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I have a history of heart problems or am at risk for them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response

Secondary study objectives

objective response rate (ORR)

safety

Side effects data

From 2015 Phase 3 trial • 675 Patients • NCT01006980

56%

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%

Constipation

15%

Oedema Peripheral

15%

Asthenia

15%

Myalgia

15%

Cough

14%

Seborrhoeic Keratosis

13%

Actinic Keratosis

13%

Musculoskeletal Pain

12%

Melanocytic Naevus

12%

Dizziness

12%

Skin Lesion

11%

Keratoacanthoma

11%

Abdominal Pain Upper

11%

Nasopharyngitis

11%

Insomnia

10%

Blood Alkaline Phosphatase Increased

10%

Anaemia

10%

Weight Decreased

10%

Dyspnoea

10%

Abdominal Pain

10%

Keratosis Pilaris

10%

Palmar-Plantar Erythrodysaesthesia Syndrome

10%

Rash Maculo-Papular

Influenza Like Illness

Blood Bilirubin Increased

Pain

Paraesthesia

Blood Creatinine Increased

Dermal Cyst

Chest Pain

Peripheral Swelling

Oropharyngeal Pain

Alanine Aminotransferase Increased

Folliculitis

Chills

Gamma-Glutamyltransferase Increased

Aspartate Aminotransferase Increased

Dyspepsia

Conjunctivitis

Upper Respiratory Tract Infection

Depression

Abdominal Distension

Dermatitis Acneiform

Influenza

Hyperaesthesia

Skin Exfoliation

Flushing

Acne

Rash erythematous

Basal cell carcinoma

Urinary tract infection

Lower respiratory tract infection

Malignant melanoma

Seizure

Abdominal pain

Pulmonary embolism

Thrombocytopenia

Dehydration

Pleuritic pain

Uveitis

Pancreatitis

Atrial fibrillation

Myocardial infarction

Chest pain

Pneumonia

Blood bilirubin increased

Gamma-glutamyltransferase increased

Acute kidney injury

Pleural effusion

Blood alkaline phosphatase increased

Gastrointestinal haemorrhage

Bowen's disease

Loss of consciousness

100%

80%

60%

40%

20%

Study treatment Arm

Vemurafenib

Vemurafenib After Crossover

Dacarbazine

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: 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

~3550

0 / 18Eligibility criteria met