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Kinase Inhibitor

binimetinib for Melanoma

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose up to 1 year after treatment initiation
Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for advanced melanoma in adolescents. The safety and effectiveness of the treatment will be studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose up to 1 year after treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to 1 year after treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK parameter (AUClast) for AR00426032
PK parameter (AUClast) for LHY746
PK parameter (AUClast) for encorafenib
+17 more
Secondary outcome measures
Bone and Bones
Change from Baseline in calcium-phosphorus product (Ca × P)
Change from baseline bone age and the difference in bone age and chronological age
+9 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%
Hypertension
11%
Paronychia
11%
Dysphonia
11%
Hypokalaemia
11%
Periorbital oedema
11%
Dry mouth
11%
Abdominal distension
11%
Amylase increased
11%
Rash maculo-papular
11%
Stomatitis
11%
Myalgia
7%
Urinary tract infection
7%
Subretinal fluid
7%
Hyperhidrosis
7%
Rash pustular
7%
Hypoalbuminaemia
7%
Hypophosphataemia
7%
Rash macular
7%
Wheezing
7%
Pericardial effusion
7%
Cardiac failure
7%
Macular oedema
7%
Aspartate aminotransferase increased
7%
Platelet count decreased
7%
Tumour associated fever
7%
Dizziness
7%
Haematuria
7%
Dry skin
7%
Alopecia
7%
Alanine aminotransferase increased
7%
Proctalgia
7%
Blood bilirubin increased
7%
Lipase increased
4%
Rash papular
4%
Rash pruritic
4%
Myositis
4%
Pneumonitis
4%
Hypocalcaemia
4%
Hypotension
4%
Infusion related reaction
4%
Lung infection
4%
Eyelid oedema
4%
Ataxia
4%
Pain
4%
Hypomagnesaemia
4%
Nephritis
4%
Hyperglycaemia
4%
Myocarditis
4%
Intestinal obstruction
4%
Infected seroma
4%
Klebsiella bacteraemia
4%
Pain in extremity
4%
Pulmonary oedema
4%
Superior vena cava syndrome
4%
Haemorrhoids
4%
Blood alkaline phosphatase increased
4%
Weight decreased
4%
Troponin I increased
4%
Proteinuria
4%
Renal colic
4%
Epistaxis
4%
Rales
4%
Arthralgia
4%
Hyponatraemia
4%
Dyspepsia
4%
Gamma-glutamyltransferase increased
4%
Neuropathy peripheral
4%
Depression
4%
Localised oedema
4%
Dysgeusia
4%
Vision blurred
4%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Nivolumab+Binimetinib
Phase 2: Nivolumab+Ipilimumab+Binimetinib
Phase 1b: Nivolumab+Binimetinib
Phase 1b: Nivolumab+Ipilimumab+Binimetinib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Run-in PhaseExperimental Treatment2 Interventions
binimetinib taken twice daily (BID) and encorafenib taken once daily (QD) Dose levels by patient body surface area (BSA) for binimetinib and encorafenib tablets/capsules are specified in the protocol.
Group II: Expansion PhaseExperimental Treatment2 Interventions
binimetinib taken twice daily (BID) and encorafenib taken once daily (QD) Dose levels by patient body surface area (BSA) for binimetinib and encorafenib tablets/capsules and pediatric formulations are specified in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
binimetinib
2017
Completed Phase 2
~80
encorafenib
2019
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Pierre Fabre LaboratoriesIndustry Sponsor
24 Previous Clinical Trials
39,093 Total Patients Enrolled
2 Trials studying Melanoma
84 Patients Enrolled for Melanoma
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,908,049 Total Patients Enrolled
51 Trials studying Melanoma
49,452 Patients Enrolled for Melanoma
Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer
22 Previous Clinical Trials
6,606 Total Patients Enrolled
1 Trials studying Melanoma
183 Patients Enrolled for Melanoma

Frequently Asked Questions

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

What therapeutic ailments is binimetinib primarily used to address?

"Binimetinib can be employed to treat individuals afflicted with braf v600k mutation, metastatic melanoma, and/or unresectable melanoma."

Answered by AI

Are there any possibilities to join this trial at present?

"Yes, the information posted to clinicaltrials.gov attests that this medical trial is accepting applicants. It was originally listed on August 3rd 2020 and recently modified on November 22nd 2022. The study requires 18 participants from 3 sites."

Answered by AI

What is the estimated size of the population participating in this clinical trial?

"This study necessitates the inclusion of 18 individuals that match its criteria. The medical trial sites, which include UPMC Children's Hospital of Pittsburgh and The University of Texas MD Anderson Cancer Center, are located in Pittsburgh, Pennsylvania and Houston, Texas respectively."

Answered by AI

Could you provide a summary of prior experiments involving binimetinib?

"Currently, 63 clinical research studies are underway investigating the efficacy of binimetinib. 4 of those trials have entered Phase 3 and 3543 trial sites are conducting these experiments across the country with a major hub located in Orange City, Florida."

Answered by AI

Has binimetinib been given the green light by the FDA?

"Due to the limited data available on binimetinib's efficacy and safety, it has been rated a 1 on our team at Power's scale."

Answered by AI

Does this clinical investigation accept individuals of eighteen years or older?

"This clinical trial requires that participants are between 12 and 17 years old, inclusive."

Answered by AI

Is this particular investigation pioneering in its approach?

"Research into binimetinib has been ongoing since 2011, when a 183-patient trial was sponsored by Pfizer. Subsequently, this medication received Phase 2 drug approval and is now the subject of 63 active studies in 1256 cities across 41 nations."

Answered by AI

What criteria must potential participants meet to be eligible for this experiment?

"Eligibility for this clinical trial requires that patients have melanoma and are aged between 12-17 years old. As of now, approximately 18 potential participants have been accepted to the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
2020. "Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03878719.
~0 spots leftby Apr 2025
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