Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Advanced Solid Tumors, Metastatic Melanoma, solid tumor, melanoma, Losartan, Midazolam, Levomethorphan, Dextromethorphan, Caffeine, Modafinil, Bupropion, Omeprazole, Rosuvastatin Calcium, rosuvastatin, bupropion immediate release (IR), encorafenib, binimetinib, CYP Probe Cocktail, Rosuvastatin and Bupropion

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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;

Locations

  • UC Irvine Health
    Orange California 92868-3201 United States
  • Utah Cancer Specialists
    West Valley City Utah 84119 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03864042
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 56 people participating
Last Updated