NCT01519011 - Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 7, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

May 12, 2015

Conditions

Myelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Acute

Interventions

DRUG

oral azacitidine

oral azacitidine 300-mg once daily for 3 total doses with two 150-mg tablets (fasted and fed) or three 100-mg tablets (fasted).

DRUG

oral azacitidine

300-mg (three 100-mg tablets) once daily for 21 days of a 28-day cycle.

Trial Locations (8)

Virginia Oncology Associates, Norfolk

Sarah Cannon Cancer Center, Nashville

Texas Oncology, Dallas

Comprehensive Cancer Centers of Nevada, Las Vegas

Moores UCSD Cancer Center MC-0987, La Jolla

Northwest Cancer Specialists, P.C., Vancouver

Rocky Mountain Cancer Center, Denver

University of Cincinnati Physician's Inc., Cincinnati