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Kinase Inhibitor

Vemurafenib for Advanced Cancers with BRAF V600 Mutations

Phase 2

Waitlist Available

Led By AeRang Kim

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

Patients must not have received prior exposure to a BRAF inhibitor (e.g. vemurafenib, dabrafenib or encorafenib)

Specified criteria for creatinine clearance or radioisotope glomerular filtration rate (GFR), bilirubin, serum glutamate pyruvate transaminase (SGPT), serum albumin, corrected QT (QTc) interval, and ability to swallow intact tablets must be met

Must not have

Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant

Patients who are currently receiving drugs that are inhibitors or inducers of p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G, member 2 (ABCG2 [BCRP])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations.

Who is the study for?

This trial is for kids and teens with advanced solid tumors, lymphoma, or histiocytic disorders that have a specific mutation (BRAF V600) and haven't responded to other treatments. They should be recovering from previous therapies, able to perform daily activities at least minimally despite any neurological issues, and not have been treated with BRAF inhibitors before.

What is being tested?

The study tests how well vemurafenib works on patients with certain mutations in their cancer cells. It's designed to see if this drug can stop the growth of tumor cells by blocking enzymes they need to grow. The trial includes lab biomarker analysis as part of its procedures.

What are the potential side effects?

Vemurafenib may cause side effects like rash, joint pain, fatigue, hair loss, heart problems (like changes in heartbeat), liver problems (like hepatitis), skin growths or cancers (like cutaneous squamous cell carcinoma), sensitivity to sunlight, and eye problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with a BRAF inhibitor.

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My kidney, liver functions, heart rhythm, and ability to swallow pills are within normal ranges.

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My cancer has spread to the lining of my brain or spinal cord but can't be measured by standard methods.

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My blood counts meet the required levels and I don't have cancer in my bone marrow.

Exclusion Criteria

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

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I am not taking medication that affects p-glycoprotein or ABCG2.

Select...

I am not taking drugs that strongly affect liver enzyme CYP3A4.

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I have an active type of skin cancer known as squamous cell carcinoma.

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My brain tumor is classified as low grade (WHO grades I or II).

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I do not have any infections that are currently uncontrolled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Progress Free Survival (PFS)

Other study objectives

Changes in Tumor Genomics

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: Treatment (vemurafenib)Experimental Treatment2 Interventions

Patients receive vemurafenib PO BID on day 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3550

0 / 10Eligibility criteria met