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MEK Inhibitor

Binimetinib for Hairy Cell Leukemia

Q: Could you please tell us the side effects of binimetinib?

binimetinib received a safety score of 2. This is due to the fact that it is only in Phase 2 trials, meaning while there are some data supporting its safety, there are no reports yet on whether or not the medication is effective.

Q: What is the scientific community's opinion of binimetinib?

There are 3 Phase 3 trials and 59 total studies being conducted worldwide to investigate the efficacy of binimetinib. The many studies for binimetinib are based primarily in Melbourne, Victoria, but there are 3043 locations running clinical trials for this treatment globally.

Q: How many people have been given the opportunity to participate in this clinical trial?

Yes, the correct. The information present on clinicaltrials.gov indicates that this trial is looking for participants. This trial was first posted on 1/7/2021 and updated most recently on 11/3/2022. 40 people are needed from 1 site.

Q: To what ailments does binimetinib lend a therapeutic hand?

Patients with the BRAF V600K mutation, those suffering from metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and those with unresectable melanoma can <a href="https://www.withpower.com/clinical-trials/all">all</a> be treated using binimetinib.

Q: Can new people still sign up for this experiment?

This study, which was originally posted on 1/7/2021 and last updated on 11/3/2022, is currently recruiting patients.

Q: Has anything like this been done before?

binimetinib has been studied since 2012. The first study took place in 2012 and was sponsored by Pfizer. Following the first trial in 2012, which involved 189 patients, binimetinib received its Phase 1 &#x26; 2 drug approval. As of now, there are 59 live trials for binimetinib being conducted across 1112 cities and 39 countries worldwide.

Phase 2

Recruiting

Led By Robert J Kreitman, M.D.

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

Participants must have adequate organ and marrow function as defined below: Total bilirubin less than or equal to 3x upper limit of normal (ULN), AST and ALT less than or equal to 3x ULN, Alkaline phosphatase < 2.5x ULN, Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR, Serum albumin greater than or equal to 2 g/dL, Prothrombin time (PT)/International Normalized Ratio < 2.5x ULN (If on warfarin, PT/INR < 3.5x ULN; If on any other anticoagulation, Prothrombin time (PT) < 2.5x ULN, Fibrinogen greater than or equal to 0.5x lower limit of normal

Refractory or relapsed disease - defined as either: Refractory- no response or disease progression in less than or equal to 1 year following first-line treatment with a purine analog, or Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every year

Awards & highlights

Study Summary

This trial is testing the effectiveness of binimetinib, a drug that targets the MEK gene, in treating hairy cell leukemia that does not have a BRAF mutation.

Who is the study for?

Adults over 18 with hairy cell leukemia that doesn't have the BRAF gene mutation, who've had their disease return or not respond to treatment. They must have certain blood count levels and organ function, agree to use contraception, and be willing to sign consent. Excluded if recently treated with other therapies, pregnant/breastfeeding, uncontrolled illnesses, active infections like HBV/HCV or HIV without proper control.Check my eligibility

What is being tested?

The trial is testing binimetinib—a MEK inhibitor—on participants taking it orally twice daily in cycles of 28 days. It's for those whose leukemia lacks a BRAF mutation and aims to see if this drug can effectively treat their condition when other treatments haven't worked.See study design

What are the potential side effects?

Potential side effects of binimetinib may include fatigue, high blood pressure, rash or skin changes, blurred vision due to eye problems (like retinal vein occlusion), muscle pain or weakness (elevated CK), heart issues including chest pain/heart attack/stroke symptoms.

Eligibility Criteria

Inclusion Criteria

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

Select...

My liver, kidney, and blood functions meet the required levels for the trial.

Select...

My disease did not improve or worsened within a year after treatment, or it came back after treatment.

Select...

My cancer is confirmed as hairy cell leukemia (HCL) or its variant (HCLv).

Select...

My cancer is BRAF wild-type as confirmed by a recent test.

Select...

I am 18 years old or older.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every year

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

overall response rate

Secondary outcome measures

CR rate

Overall survival

Progression free survival

+3 more

Side effects data

From 2021 Phase 2 trial • 75 Patients • NCT03271047

52%

Blood creatine phosphokinase increased

48%

Diarrhoea

48%

Dermatitis acneiform

48%

Decreased appetite

44%

Nausea

41%

Fatigue

33%

Constipation

30%

Rash

30%

Oedema peripheral

30%

Pyrexia

26%

Vomiting

26%

Anaemia

26%

Asthenia

22%

Cough

19%

Abdominal pain

19%

Back pain

19%

Pruritus

15%

Face oedema

15%

Ascites

15%

Dyspnoea

15%

Ejection fraction decreased

15%

Chills

11%

Dysphonia

11%

Paronychia

11%

Periorbital oedema

11%

Hypokalaemia

11%

Hypertension

11%

Dry mouth

11%

Abdominal distension

11%

Amylase increased

11%

Rash maculo-papular

11%

Stomatitis

11%

Myalgia

Urinary tract infection

Hyperhidrosis

Wheezing

Rash pustular

Hypophosphataemia

Subretinal fluid

Rash macular

Hypoalbuminaemia

Pericardial effusion

Cardiac failure

Macular oedema

Aspartate aminotransferase increased

Platelet count decreased

Tumour associated fever

Dizziness

Haematuria

Dry skin

Alopecia

Alanine aminotransferase increased

Proctalgia

Blood bilirubin increased

Lipase increased

Hyperglycaemia

Rash papular

Rash pruritic

Myositis

Hypotension

Infusion related reaction

Eyelid oedema

Nephritis

Hypomagnesaemia

Lung infection

Ataxia

Pain

Hypocalcaemia

Pneumonitis

Myocarditis

Intestinal obstruction

Infected seroma

Klebsiella bacteraemia

Pain in extremity

Pulmonary oedema

Superior vena cava syndrome

Haemorrhoids

Blood alkaline phosphatase increased

Weight decreased

Troponin I increased

Proteinuria

Renal colic

Epistaxis

Rales

Arthralgia

Hyponatraemia

Dyspepsia

Gamma-glutamyltransferase increased

Neuropathy peripheral

Depression

Localised oedema

Dysgeusia

Vision blurred

Influenza like illness

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2: Nivolumab+Binimetinib

Phase 2: Nivolumab+Ipilimumab+Binimetinib

Phase 1b: Nivolumab+Binimetinib

Phase 1b: Nivolumab+Ipilimumab+Binimetinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1/Experimental therapyExperimental Treatment1 Intervention

Treatment with binimetinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

binimetinib

2017

Completed Phase 2

~80

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,814 Total Patients Enrolled

Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)

12 Previous Clinical Trials

2,188 Total Patients Enrolled

Media Library

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04322383 — Phase 2

Hairy Cell Leukemia Research Study Groups: Arm 1/Experimental therapy

Hairy Cell Leukemia Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04322383 — Phase 2

Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322383 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell us the side effects of binimetinib?

"binimetinib received a safety score of 2. This is due to the fact that it is only in Phase 2 trials, meaning while there are some data supporting its safety, there are no reports yet on whether or not the medication is effective."

Answered by AI

What is the scientific community's opinion of binimetinib?

"There are 3 Phase 3 trials and 59 total studies being conducted worldwide to investigate the efficacy of binimetinib. The many studies for binimetinib are based primarily in Melbourne, Victoria, but there are 3043 locations running clinical trials for this treatment globally."

Answered by AI

How many people have been given the opportunity to participate in this clinical trial?

"Yes, the correct. The information present on clinicaltrials.gov indicates that this trial is looking for participants. This trial was first posted on 1/7/2021 and updated most recently on 11/3/2022. 40 people are needed from 1 site."

Answered by AI

To what ailments does binimetinib lend a therapeutic hand?

"Patients with the BRAF V600K mutation, those suffering from metastatic melanoma, and those with unresectable melanoma can all be treated using binimetinib."

Answered by AI

Can new people still sign up for this experiment?

"This study, which was originally posted on 1/7/2021 and last updated on 11/3/2022, is currently recruiting patients."

Answered by AI

Has anything like this been done before?

"binimetinib has been studied since 2012. The first study took place in 2012 and was sponsored by Pfizer. Following the first trial in 2012, which involved 189 patients, binimetinib received its Phase 1 & 2 drug approval. As of now, there are 59 live trials for binimetinib being conducted across 1112 cities and 39 countries worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant

2021. "Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322383.

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