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

COMPLETEDPHASE1

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

NCT03864042•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or IV; or other BRAF V600-mutant advanced solid tumors
•Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to enrollment, as determined using a local test;
•Evidence of measurable or non-measurable lesions
•Patient with unresectable locally advanced or metastatic melanoma who has received no prior treatment or progressed on or after prior systemic therapy; Note: Prior therapy with a BRAF proto-oncogene serine-threonine protein kinase (BRAF) inhibitor and/or a mitogen-activated protein (MAP) kinase (MEK) inhibitor is permitted except in the regimen immediately prior to study entry
•Patient with other (non-melanoma) BRAF V600E and/or V600K -mutant advanced solid tumors who has progressed on standard therapy or for whom there are no available standard therapies; Note: Prior therapy with a BRAF inhibitor and/or a MEK inhibitor is permitted except in the regimen immediately prior to study entry
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
•Adequate bone marrow, hepatic and renal function as specified in the protocol
•ARM 1 ONLY: Non-smoker who has not used nicotine containing products for at least 3 months prior to the first dose.

Exclusion Criteria

•Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable, with imaging (e.g., magnetic resonance imaging \[MRI\] or computed tomography \[CT\] demonstrating no current evidence of progressive brain metastases at screening);
•Symptomatic or untreated leptomeningeal disease;
•History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes);
•Clinically significant cardiac disease
•Known hyper-coagulability risks other than malignancy (e.g., Factor V Leiden syndrome);
•Thromboembolic event except catheter-related venous thrombosis ≤ 12 weeks prior to starting study treatment.
•Discontinuation of prior BRAF and/or MEK inhibitor treatment due to left ventricular dysfunction, pneumonitis/interstitial lung disease, or retinal vein occlusion;
•ARM 1 ONLY: Positive urine cotinine test at screening
•ARM 3 ONLY:
•* History of psychosis, depression or mania;
+3 more criteria

Locations (29)

UC Irvine Health

Orange, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Hopkins Eye Clinic

Hopkins, Minnesota, United States

Park Nicollet Eye Clinic

Maple Grove, Minnesota, United States

Regions Cancer Care Center

Saint Paul, Minnesota, United States

HealthPartners Specialty Center-Eye Care

Saint Paul, Minnesota, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

University of TN Medical Center

Knoxville, Tennessee, United States

Mary Crowley Cancer Research - Medical City Hospital

Dallas, Texas, United States

Key Dates

Start Date

January 2, 2018

Primary Completion Date

July 11, 2022

Completion Date

May 29, 2023

Last Updated

September 27, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorsMetastatic Melanoma

Interventions

losartan

DRUG

dextromethorphan

DRUG

caffeine

DRUG

omeprazole

DRUG

midazolam

DRUG

rosuvastatin

DRUG

bupropion immediate release (IR)

DRUG

encorafenib

DRUG

binimetinib

DRUG

modafinil

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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