drugset / Trial / NCT02196857

Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation

NCT02196857 ↗

Phase 2 Completed 16 enrolled M.D. Anderson Cancer Center Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD mutation. The safety of this drug combination will also be studied.

Timeline

Start
2015-02-06
Primary completion
2018-11-27
Completion
2018-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacytidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Sorafenib Small molecule 400 mg Oral

Indications