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Kinase Inhibitor

encorafenib 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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up multiple timepoints over 8 hours post dose on day 15 and day 21 in arm 3 (drug-drug interaction (ddi) phase)

Awards & highlights

Study Summary

This trial is testing how well a combination of two drugs, encorafenib and binimetinib, works at different doses in people with cancer. The trial will also look at how well a third drug, modafinil, works with the combination of encorafenib and binimetinib.

Eligible Conditions

Metastatic Melanoma
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple timepoints over 8 hours post dose on day 15 and day 21 in arm 3 (drug-drug interaction (ddi) phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple timepoints over 8 hours post dose on day 15 and day 21 in arm 3 (drug-drug interaction (ddi) phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple timepoints over 8 hours post dose on day 15 and day 21 in arm 3 (drug-drug interaction (ddi) phase) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Changes in plasma encorafenib and LHY746 Cmax and area under the concentration time curve (AUC) in Arm 3.

Changes in the amount of probe eliminated via urine over an 8-hour period (Ae0-8) in Arm 1

Probe substrate concentration from time zero to the time of last quantifiable concentration (AUClast) in Arms 1 and 2

+1 more

Secondary outcome measures

Metabolite ratio (MRAUC) for 1-OH midazolam/midazolam, paraxanthine/caffeine, 5-hydroxy omeprazole/omeprazole, hydroxybupropion/bupropion and LHY746/encorafenib

Metabolite ratio (MRCmax) for 1-OH midazolam/midazolam, paraxanthine/caffeine, 5-hydroxy omeprazole/omeprazole, hydroxybupropion/bupropion and LHY746/encorafenib

Metabolite ration (MRAe0-8) for E-3174/losartan and dextrorphan/dextromethorphan

+21 more

Side effects data

From 2023 Phase 2 trial • 95 Patients • NCT03693170

67%

Diarrhoea

44%

Nausea

40%

Rash

40%

Dermatitis acneiform

36%

Vomiting

33%

Abdominal pain

32%

Asthenia

32%

Dry skin

26%

Constipation

24%

Anaemia

23%

Decreased appetite

19%

Fatigue

16%

Dyspnoea

14%

Vision blurred

13%

Pyrexia

13%

Dysgeusia

13%

Lipase increased

13%

Pruritus

12%

Skin fissures

12%

Paronychia

11%

Amylase increased

11%

Headache

Back pain

Blood creatinine increased

Stomatitis

Arthralgia

Cough

Dyspepsia

Abdominal pain upper

Hypoalbuminaemia

Rectal haemorrhage

Weight decreased

Large intestinal obstruction

Abdominal discomfort

Dysphonia

Myalgia

Hypertrichosis

Hypomagnesaemia

Mucosal inflammation

Acute kidney injury

Intestinal obstruction

Insomnia

Muscle spasms

Palmar-plantar erythrodysaesthesia syndrome

Blood creatine phosphokinase increased

Erythema

Flatulence

Hyperkalaemia

Small intestinal obstruction

Renal failure

Respiratory tract infection

Biliary tract infection

Lower gastrointestinal haemorrhage

Escherichia sepsis

Cellulitis

Lymph node tuberculosis

Respiratory failure

Diverticulum

Enteritis

Enterocolitis

Intra-abdominal fluid collection

Large intestine perforation

Sepsis

Urinary tract infection

Diversion colitis

Femoral neck fracture

Infusion related reaction

Lumbar vertebral fracture

Cardiac failure

Myocardial infarction

Myocarditis

Pancreatitis acute

Subileus

General physical health deterioration

Bile duct stenosis

Cholangitis

Cholecystitis

Hepatic function abnormal

Appendicitis

Bacteraemia

Streptococcal bacteraemia

Tuberculosis

Detachment of retinal pigment epithelium

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood bilirubin increased

Gamma-glutamyltransferase increased

Hypokalaemia

Tumour associated fever

Dizziness

Haematuria

Nephritis

Nephrolithiasis

Pleural effusion

Pneumonia aspiration

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

1 Arm

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3 - ModafinilExperimental Treatment3 Interventions

Patients will begin encorafenib/binimetinib continuous daily dosing starting Day 1: 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) then receive continuous treatment of modafinil on Day 15 through Day 21: - 400 mg modafinil tablet once daily (QD)

Group II: Arm 2 - Rosuvastatin and BupropionExperimental Treatment4 Interventions

Patients will receive a single oral dose of rosuvastatin and bupropion once on Day -7, Day 1 and Day 14: 10 mg rosuvastatin oral tablet 75 mg bupropion immediate release (IR) oral tablet encorafenib/binimetinib continuous daily dosing starting Day 1: 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes.

Group III: Arm 1 - CYP Probe CocktailExperimental Treatment7 Interventions

Patients will receive a single oral dose of the CYP Probe Cocktail on Day -7, Day 1, and Day 14: 25 mg losartan oral tablet 30 mg dextromethorphan oral capsule 50 mg caffeine oral liquid 20 mg omeprazole oral capsule 2 mg midazolam oral syrup encorafenib/binimetinib continuous daily dosing starting Day 1: 450 mg (6 x 75 mg) encorafenib oral capsules once daily (QD) 45 mg (3 x 15 mg) binimetinib oral tablet twice daily (BID) All drugs will be taken within 10 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

caffeine

2010

Completed Phase 4

~1760

dextromethorphan

2012

Completed Phase 4

~260

omeprazole

2011

Completed Phase 4

~4239590

midazolam

2019

Completed Phase 4

~3010

binimetinib

2017

Completed Phase 2

~80

modafinil

2011

Completed Phase 4

~310

losartan

2013

Completed Phase 4

~1440

encorafenib

2019

Completed Phase 2

~100

rosuvastatin

2013

Completed Phase 4

~4780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,817 Total Patients Enrolled

51 Trials studying Melanoma

49,397 Patients Enrolled for Melanoma

Pierre Fabre LaboratoriesIndustry Sponsor

24 Previous Clinical Trials

39,038 Total Patients Enrolled

2 Trials studying Melanoma

29 Patients Enrolled for Melanoma

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,092,985 Total Patients Enrolled

25 Trials studying Melanoma

3,371 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 conditions are typically treated with encorafenib?

"Through the use of encorafenib, patients can find relief from pain management issues, unusual seizure patterning and hypertriglyceridemias."

Answered by AI

To what extent can encorafenib be detrimental to human health?

"Due to early clinical data, our team at Power has assigned encorafenib a safety rating of 1. This is because it's currently in the first phase of its trial and there are limited records supporting efficacy and safety measures."

Answered by AI

Could you detail other research projects which have utilized encorafenib?

"The first trials researching the efficacy of encorafenib occurred in 1997 at Vanderbilt University Autonomic Dysfunction Center. Since then, 1688 clinical studies have been completed with 253 still active today; many are situated within Salt Lake City, Utah."

Answered by AI

Is this trial still enrolling participants?

"Unfortunately, this particular trial is not presently recruiting patients. The first listing was posted on February 1st of 2018 and the study's latest update came on November 22nd 2022. However, if you are seeking alternative clinical trials, there currently exists 1213 studies that accept participants with metastatic melanoma and 253 trials for encorafenib admission available."

Answered by AI

How many health care facilities have adopted this experiment?

"This medical trial is distributing its services across 20 separate sites, most notably Utah Cancer Specialists in Salt Lake City, Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc. in Fountain Valley and University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) in Aurora."

Answered by AI

How many participants are eligible to join this research project?

"Currently, this trial is not accepting new enrollees. It was first listed on the 2nd of January 2018 and has been revised most recently on November 22nd 2022. If you are looking for alternative medical studies, there are 1213 trials actively recruiting patients with metastatic melanoma and 253 clinical tests searching for participants utilizing encorafenib."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

2018. "Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03864042.

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