Status:
COMPLETED
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Pierre Fabre Laboratories
Conditions:
Advanced Solid Tumors
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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)...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03864042
Start Date
January 2 2018
End Date
May 29 2023
Last Update
September 27 2024
Active Locations (29)
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1
UC Irvine Health
Orange, California, United States, 92868-3201
2
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
4
Hopkins Eye Clinic
Hopkins, Minnesota, United States, 55343-8087