Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria - Patients must meet all of the inclusion criteria to be eligible for enrollment into the study:

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.

Key Exclusion Criteria - Patients meeting any of the following criteria are not eligible for enrollment in the study:

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;
History of angioedema;
History of mitral valve prolapse;
History of left ventricular hypertrophy;

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT03864042

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 24 Locations for this study

See Locations Near You

UC Irvine Health
Orange California, 92868, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora Colorado, 80045, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Regions Cancer Care Center
Saint Paul Minnesota, 55101, United States
HealthPartners Specialty Center-Eye Care
Saint Paul Minnesota, 55130, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
University of TN Medical Center
Knoxville Tennessee, 37920, United States
Mary Crowley Cancer Research - Medical City Hospital
Dallas Texas, 75230, United States
Utah Cancer Specialists
West Valley City Utah, 84119, United States
Universitair Ziehenhuis Antwerpen
Edegem , 2650, Belgium
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
McGill University Health Center
Montreal Quebec, H4A 3, Canada
Jewish General Hospital
Montrea Quebec, H3T 1, Canada
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Erasmus Medical Center
Rotterdam , 3000 , Netherlands
Hospital del Mar
Barcelona , 08003, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar , 30120, Spain
Hospital Universitari Arnau de Vilanova
Lleida , 25198, Spain
Hospital Beata Maria Ana
Madrid , 28007, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Clinica Rementeria
Madrid , 28010, Spain
MD Anderson Cancer Center Madrid
Madrid , 28033, Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid , 28050, Spain
CERCO
Sevilla , 41009, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT03864042

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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