Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 12, 2008

Primary Completion Date

April 6, 2016

Study Completion Date

April 7, 2016

Conditions
Acute Myeloid LeukemiaMyelodysplastic SyndromesLymphomaMultiple MyelomaLeukemia, Myelomonocytic, Chronic
Interventions
DRUG

azacitidine

"Arm 1:~Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.~Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.~Arm 2:~All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle."

Trial Locations (11)

34761

Main Cancer Centers of Florida, P.A., Ocoee

46202

Indiana University School of Medicine, Indianapolis

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

77030

University of Texas- MD Anderson, Houston

78229

Hematology and Oncology Assoc. of South Texas, San Antonio

87109

Northwest Cancer Specialists, P.C., Albuquerque

94904

California Cancer Care Inc, Greenbrae

97477

Willamette Valley Cancer Institute, Springfield

98902

Yakima Valley Memorial Hospital/ North Star Lodge, Yakima

98109-4417

Fred Hutchinson Cancer Research Center, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT00761722 - Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma | Biotech Hunter | Biotech Hunter