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MEK Inhibitor
Binimetinib for Cancer
Phase 2
Waitlist Available
Led By James M Cleary
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 have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically significant abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Creatinine =< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights
Study Summary
This trial tests whether binimetinib can shrink or stop the growth of cancer with an NRAS mutation.
Who is the study for?
This trial is for patients with various cancers, like lymphoma and multiple myeloma, that have a specific NRAS genetic change. Participants need to have good kidney function, normal heart rhythm and ejection fraction, and no severe gastrointestinal issues or active brain lesions. Those with melanoma, previous MEK inhibitor treatments, certain eye diseases or uncontrolled hypertension can't join.Check my eligibility
What is being tested?
The trial is testing Binimetinib's effectiveness on cancers with the NRAS mutation. Binimetinib targets proteins involved in cancer cell growth. The study aims to see if it can shrink these cancers or halt their progression.See study design
What are the potential side effects?
Potential side effects of Binimetinib may include abnormal heart rhythms due to its effect on cardiac proteins, digestive problems since it can affect gastrointestinal function, visual disturbances related to retinal health concerns, and possibly increased blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent ECG showed no significant heart issues.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
My cancer has an NRAS mutation in specific areas.
Select...
My heart pumps well and my heart's electrical activity is normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
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 (ORR)
Secondary outcome measures
6-Month Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)
Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT0292822478%
Diarrhoea
68%
Dermatitis acneiform
59%
Nausea
54%
Fatigue
51%
Vomiting
51%
Dry Skin
43%
Pyrexia
43%
Anaemia
41%
Decreased appetite
38%
Abdominal pain
38%
Constipation
35%
Dyspnoea
32%
Vision blurred
30%
Blood creatine increased
30%
Blood creatine phosphokinase increased
24%
Arthralgia
24%
Myalgia
24%
Skin fissures
22%
Back Pain
22%
Dizziness
19%
Malaise
19%
Urinary tract infection
19%
Headache
19%
Aspartate aminotransferase increased
16%
Asthenia
16%
Oedema peripheral
16%
Stomatitis
16%
PPE syndrome
16%
Hypomagnesaemia
16%
Rash maculo-papular
16%
Palmar-planar erythrodysaesthesia
16%
Chills
16%
Paronychia
16%
Rash pustular
16%
Alanine aminotransferase increased
16%
Dysgeusia
16%
Peripheral sensory neuropathy
14%
Cough
14%
Abdominal pain upper
14%
Infusion-related reaction
14%
Ejection fraction decreased
14%
Dry eye
11%
Trichiasis
11%
Vitreous floaters
11%
Pollakiuria
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Weight decreased
8%
Macular oedema
8%
Proteinuria
8%
Rhinitis allergic
8%
Iron deficiency
8%
Nasopharyngitis
8%
Infusion related reaction
8%
Hypertrichosis
8%
Visual impairment
8%
Hypokalaemia
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Rectal haemorrhage
5%
Hypophosphataemia
5%
Bone pain
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Urinary incontinence
5%
Musculoskeletal chest pain
5%
Pleural effusion
5%
Musculoskeletal pain
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Abdominal pain lower
5%
Nail disorder
5%
Colitis
5%
Infection
5%
Wound
5%
Anal haemorrhage
5%
Insomnia
5%
Gastroesophageal reflux disease
5%
Abdominal distension
5%
Eczema
5%
Cystitis
5%
Renal failure
5%
Conjunctivitis
5%
Syncope
5%
Dehydration
5%
Dry Mouth
5%
Skin hyperpigmentation
5%
Muscle spasms
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Large intestinal ulcer hemorrhage
3%
Urinary tract infection bacterial
3%
Back pain
3%
Kidney infection
3%
Large intestinal ulcer
3%
Upper respiratory tract infection
3%
Tumour pain
3%
Streptococcal infection
3%
Melanocytic naevus
3%
Large intestine perforation
3%
Cholangitis
3%
Device occlusion
3%
Skin papilloma
3%
Alopecia
3%
Bacterial sepsis
3%
Rhabdomyolysis
3%
Confusional state
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Urinary tract obstruction
3%
Epistaxis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Bacteria sepsis
3%
Hydronephrosis
3%
Neuropathy peripheral
3%
Abdominal abscess
3%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined Safety Lead-in
Phase 3: Triplet Arm
Phase 3: Doublet Arm
Phase 3: Control Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (binimetinib)Experimental Treatment1 Intervention
Patients receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,436 Total Patients Enrolled
James M ClearyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of eye diseases that cause vision loss.I do not have an active hepatitis B or C infection.My blood pressure is controlled with medication.I do not have a history of Gilbert's syndrome.My recent ECG showed no significant heart issues.I do not have, nor have I ever had, issues with blocked blood vessels in my eyes or conditions that could cause this.I don't have active brain tumors or cancer spread to the lining of the brain and spine.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer has an NRAS mutation in specific areas.I do not have muscle disorders like muscular dystrophy or ALS.I do not have melanoma.I have never taken MEK inhibitor medications.I do not have any major stomach or intestine problems.My heart pumps well and my heart's electrical activity is normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (binimetinib)
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.
Could you outline any prior investigations into Binimetinib?
"Currently, 59 clinical trials exploring Binimetinib are in progress with 3 of them reaching the advanced Phase 3 stage. Of these studies, most take place in Melbourne, Victoria; however there exist 3073 sites conducting research into this medication."
Answered by AI
Has Binimetinib been given the greenlight by federal regulators?
"Binimetinib's risk rating was determined to be a 2 given the Phase 2 trial nature, in which there is some data indicating its safety but none regarding efficacy."
Answered by AI
Is enrollment for this research project still available?
"This trial is not currently recruiting subjects. It was originally posted on May 31st 2016 and the details were last updated on September 13th 2022. For those searching for alternative studies, 4669 trials are presently accepting cancer patients and 59 clinical trials are actively admitting participants for Binimetinib-related research."
Answered by AI
What is the size of the sample population for this clinical examination?
"Unfortunately, the recruiting window for this trial has already closed. The original posting of this study was on May 31st 2016 and it most recently updated on September 13th 2022. If you are seeking alternative clinical trials, there are currently 4669 studies looking to recruit participants with cancer and 59 related ones searching for people to test Binimetinib's efficacy."
Answered by AI
Has this research endeavor been previously undertaken?
"Binimetinib has had a long history of clinical trials, with the first sponsored by Pfizer in 2011. After 183 patients were studied for Phase 1 efficacy, Binimetinib was approved for use and currently boasts 59 active studies across 39 countries."
Answered by AI
In what medical circumstances is Binimetinib customarily utilized?
"Binimetinib has been proven to be an effective treatment for patients with a BRAF V600K mutation, metastatic melanoma, and those who are unable to have surgery due to their melanoma."
Answered by AI
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