Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Public ClinicalTrials.gov record NCT03864042. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03864042
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- losartan Drug
- dextromethorphan Drug
- caffeine Drug
- omeprazole Drug
- midazolam Drug
- rosuvastatin Drug
- bupropion immediate release (IR) Drug
- encorafenib Drug
- binimetinib Drug
- modafinil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2018
- Primary completion
- Jul 10, 2022
- Completion
- May 28, 2023
- Last update posted
- Sep 26, 2024
2018 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Irvine Health | Orange | California | 92868-3201 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| Hopkins Eye Clinic | Hopkins | Minnesota | 55343-8087 | — |
| Park Nicollet Eye Clinic | Maple Grove | Minnesota | 55369 | — |
| Regions Cancer Care Center | Saint Paul | Minnesota | 55101 | — |
| HealthPartners Specialty Center-Eye Care | Saint Paul | Minnesota | 55130 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| University of TN Medical Center | Knoxville | Tennessee | 37920 | — |
| Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas | 75230 | — |
| Utah Cancer Specialists | West Valley City | Utah | 84119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03864042, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2024 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03864042 live on ClinicalTrials.gov.