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

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

Publication date: Mar 06, 2019

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

Concepts Keywords
AJCC V600K mutation tumor
Angioedema Catheter
ARM Clinical medicine
Asymptomatic Chemical compounds
Bone Marrow Cancer treatments
BRAF B-Raf inhibitor
BRAF Inhibitor Benzamides
Breast Melanoma
Bupropion MEK inhibitor
Catheter Encorafenib
Cocktail Array BioPharma
Computed Tomography Binimetinib
Cooperative Group Pharmacokinetics
Corticosteroid Magnetic resonance imaging
CYP2B6 Tomography
Cytochrome P450 Hepatic renal protocol
Depression MRI
Drug Interaction G uncontrolled glaucoma
Enzyme History angioedema
Epileptic Related venous thrombosis
Glaucoma Metastases stable imaging
Hepatic Hepatic renal protocol
Histologically
Hypercoagulability
Inhibitor
Interstitial Lung Disease
Kinase
Left Ventricular
Left Ventricular Hypertrophy
Leiden
Leptomeningeal
Magnetic Resonance Imaging
Malignancy
Mania
MAP Kinase
Melanoma
Metastases
Metastatic
Mitogen
Mitral Valve Prolapse
Modafinil
MRI
Mutant
Mutation
Nicotine
Ocular Hypertension
Oncogene
Pharmacokinetic
Pharmacokinetics
Pneumonitis
Progressive
Protocol
Psychosis
Renal
Rosuvastatin
Serine
Substrate
Substrates
Syndrome
Systemic Therapy
Test Screening
Threonine
Tumor
Urine
Venous Thrombosis

Semantics

Type Source Name
disease MESH left ventricular hypertrophy
disease DOID mitral valve prolapse
disease MESH mitral valve prolapse
disease DOID angioedema
disease MESH angioedema
disease MESH mania
disease MESH depression
disease MESH psychosis
disease DOID interstitial lung disease
disease MESH interstitial lung disease
disease MESH pneumonitis
disease MESH left ventricular dysfunction
disease MESH venous thrombosis
disease DOID syndrome
disease MESH cardiac disease
disease MESH syndromes
disease MESH hypercoagulability
disease DOID ocular hypertension
disease MESH ocular hypertension
disease DOID glaucoma
disease MESH glaucoma
disease MESH risk factors
disease DOID retinal vein occlusion
disease MESH retinal vein occlusion
gene UNIPROT CYREN
disease MESH metastasis
drug DRUGBANK Nicotine
disease MESH smoker
disease MESH renal
gene UNIPROT MAP2K7
gene UNIPROT SGSM3
drug DRUGBANK L-Threonine
drug DRUGBANK Serine
disease DOID Cancer
disease DOID cutaneous melanoma
disease MESH diagnosis
gene UNIPROT SLC35G1
drug DRUGBANK Didanosine
drug DRUGBANK Modafinil
drug DRUGBANK Bupropion
gene UNIPROT CYP2B6
drug DRUGBANK Rosuvastatin
gene UNIPROT ABCG2
gene UNIPROT SLCO1A2
pathway BSID Breast cancer
disease DOID breast cancer
disease MESH breast cancer
gene UNIPROT PPIG
disease MESH multiple
gene UNIPROT ARMC9
gene UNIPROT AKR1A1
disease MESH Tumors
pathway BSID Melanoma
disease DOID Melanoma
disease MESH Melanoma
gene UNIPROT BRAF
drug DRUGBANK Binimetinib
drug DRUGBANK Encorafenib
disease MESH drug Interaction

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