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

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 6, 2015

Primary Completion Date

November 27, 2018

Study Completion Date

November 27, 2018

Conditions
Leukemia
Interventions
DRUG

Azacytidine

75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.

DRUG

Sorafenib

400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT02196857 - Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation | Biotech Hunter | Biotech Hunter