Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Leukemia
Interventions
DRUG

Azacitidine

75 mg/m\^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle.

DRUG

Sorafenib

Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Onyx Therapeutics, Inc.

INDUSTRY

collaborator

Celgene

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER