Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Central Nervous System Stimulants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Antihypertensive Agents

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Lipid Regulating Agents

Gastrointestinal Agents

Analgesics

Antitussive Agents

Respiratory System Agents

Bone Density Conservation Agents

Vasoconstrictor Agents

Cardiotonic Agents

Anti-Obesity Agents

Other Dietary Supplements

Caffeine

Losartan

Midazolam

Rosuvastatin Calcium

Modafinil

Omeprazole

Levomethorphan

Dextromethorphan

Bupropion

Calcium

Calcium, Dietary

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Phosphodiesterase Inhibitors

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Cytochrome P-450 Enzyme Inhibitors

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Excitatory Amino Acid Antagonists

Analgesics, Opioid

Narcotics

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.

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.

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)

losartan

dextromethorphan

caffeine

omeprazole

midazolam

rosuvastatin

bupropion immediate release (IR)

encorafenib

binimetinib

modafinil

Pfizer CT.gov Call Center

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.

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

An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Pierre Fabre Laboratories

Pfizer

Spots Global Cancer Trial Database for bupropion immediate release (ir)