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NCT03911869 · ClinicalTrials.gov registry record · Phase 2
An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03911869 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 13 participants.
The verdict
NCT03911869, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.
Interventions
- DRUG binimetinib
- DRUG encorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2022-01-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03911869
The ClinicalTrials.gov registry entry for NCT03911869 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which binimetinib is the first listed.
NCT03911869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03911869 about?
NCT03911869 is a clinical study titled "An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis". This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 p...
What is the current status of trial NCT03911869?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-04-30. Estimated completion is 2022-01-27.
What interventions are being tested in trial NCT03911869?
The interventions under investigation include: binimetinib (DRUG), encorafenib (DRUG).
Who is sponsoring clinical trial NCT03911869?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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