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Kinase Inhibitor
Encorafenib for Cancer
Phase 1 & 2
Waitlist Available
Led By Rona Yaegar, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is more effective than current treatments at stopping the growth of tumors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
dose-limiting toxicities (DLTs)
objective response rate (Phase II)
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%
Oedema peripheral
16%
Stomatitis
16%
Asthenia
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%
Infusion related reaction
8%
Weight decreased
8%
Nasopharyngitis
8%
Proteinuria
8%
Rhinitis allergic
8%
Hypokalaemia
8%
Visual impairment
8%
Hypertrichosis
8%
Iron deficiency
8%
Macular oedema
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%
Pruritus generalised
5%
Hypocalcaemia
5%
Bone pain
5%
Trichomegaly
5%
Nervous system disorder
5%
Restless legs syndrome
5%
Infection
5%
Ascites
5%
Abdominal pain lower
5%
Nail disorder
5%
Colitis
5%
Musculoskeletal pain
5%
Chorioretinopathy
5%
Musculoskeletal chest pain
5%
Pleural effusion
5%
Urinary incontinence
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%
Back pain
3%
Large intestine perforation
3%
Large intestinal ulcer hemorrhage
3%
Cholangitis
3%
Streptococcal infection
3%
Urinary tract infection bacterial
3%
Device occlusion
3%
Melanocytic naevus
3%
Skin papilloma
3%
Kidney infection
3%
Large intestinal ulcer
3%
Bacterial sepsis
3%
Tumour pain
3%
Rhabdomyolysis
3%
Confusional state
3%
Alopecia
3%
Upper respiratory tract infection
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: Binimetinib and EncorafenibExperimental Treatment2 Interventions
Patients will be initially enrolled to the approved dose of encorafenib 450 mg oral QD and binimetinib 45 mg PO BID, dose level 1. If confirmed this dose level is safely tolerated in the study population, we will then escalate treatment to dose level 2 with the novel dosing regimen of encorafenib 450 mg oral QD continuous and binimetinib 60 mg oral BID 21 days on/7 days off.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Encorafenib
2021
Completed Phase 3
~960
Find a Location
Who is running the clinical trial?
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,380 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,603 Total Patients Enrolled
Rona Yaegar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced-stage cancer that has spread to other parts of your body and standard treatments are not effective according to the doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Binimetinib and Encorafenib
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.
Has this clinical trial been used before on patients?
"Encorafenib is being trialed in 64 separate ongoing studies spread out over 1240 cities and 41 countries. The first clinical trial for Encorafenib was completed in 2012, and it involved 189 patients that went through Phase 1 & 2 of drug approval. In the 8 years since then, 28 more trials have been completed."
Answered by AI
Are there other examples of Encorafenib's efficacy?
"Encorafenib was first evaluated in 2012 by the Azienda Ospedaliera Universitaria Federico II. Since then, there have been a total of 28 completed studies. Currently, there are 64 active trials worldwide; many of which are based in Middletown, New jersey."
Answered by AI
What are the primary conditions that Encorafenib has been shown to improve?
"Encorafenib is a viable treatment option for patients with the braf v600k mutation, metastatic melanoma, and unresectable melanoma."
Answered by AI
Does this trial still have room for new participants?
"This research, as detailed on clinicaltrials.gov, is still recruiting patients. The original posting was on February 14th, 2019 with the most recent update being from May 20th, 2022."
Answered by AI
How many individuals have signed up to take part in this clinical trial?
"The listing on clinicaltrials.gov affirms that this study is open for enrollment and recruiting patients. The trial was established on February 14th, 2019 and was last updated 20 May, 2022. There are 38 slots available at 4 different research facilities."
Answered by AI
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