drugset / Trial / NCT02089230

MEK Inhibitor 162 Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Poor Prognosis, Not Suitable for or Unwilling to Receive Standard Therapy

NCT02089230

Phase 1/2 Terminated 19 enrolled M.D. Anderson Cancer Center Array BioPharma · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of MEK162 that can be given to patients with advanced leukemia. This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 57 patients total will take part in both phases of this study . All will be enrolled at MD Anderson. The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to control AML in older patients with advanced leukemia. The safety of this drug will also be studied. This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 57 patients total will take part in both phases of this study. All will be enrolled at MD Anderson.

Timeline

Start
2014-08-27
Primary completion
2019-06-05
Completion
2019-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule 15 mg Oral
Subject Binimetinib Small molecule 30 mg Oral
Subject Binimetinib Small molecule 45 mg Oral

Indications