Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, PK & PD of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML)
Optional Extension Phase (OEP) to the AZA PH US 2007 CL 005 study which allows subjects who
continue to receive oral azaitidine and have stable disease or are demonstrating clinical
benefit as assessed by the Investigator, and have consented to participate, may enter the
OEP of this study (at their current doses) at the start of their next cycle.
Subjects who are entering the OEP should be discontinued from Part 1 or Part 2 protocol
prescribed therapy in the AZA PH US 2007 CL 005 study.
Subjects may continue to receive oral azacitidine in the OEP until they meet the criteria
for study discontinuation or oral azacitidine becomes commercially available. Subjects
discontinuing from the OEP will have an OEP discontinuation visit 28 days after the last
dose of study drug or at study withdrawal.
Primary Objective of OEP is to evaluate long term safety of oral azacitidine.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety evaluation as measured by monitoring AEs, dose limiting toxicities, scheduled lab assessments, vital sign measurements, ECGs, & physical exams for study duration. Adverse changes in physical signs/symptoms will be graded according to CTC AE V.3.0.
Barry Skikne, M.D., FACP; FCP (SA)
United States: Food and Drug Administration
AZA PH US 2007 CL005
|Mayo Clinic||Rochester, Minnesota 55905|
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Virginia Oncology Associates||Newport News, Virginia 23606|
|Comprehensive Cancer Centers of Nevada||Las Vegas, Nevada 89109|
|Shands Cancer Center at the University of Florida||Gainesville, Florida 32610-0342|
|North Star Lodge Cancer Center||Yakima, Washington 98902|
|University of Chicago||Chicago, Illinois 60637|
|Kansas University Medical Center||Kansas City,, Kansas 66160-7390|
|Texas Oncology Cancer Center||Austin, Texas 78731|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|Kansas City VA Medical Center||Kansas City, Missouri 64128|
|New York Oncology Hematology P.C.||Albany, New York 12208|
|Institute of Translational Oncology Research||Greenville, South Carolina 29605|
|Gabrail Cancer Center Reearch||Canton, Ohio 44718|
|MD Anderson - University of Texas||Houston, Texas 77030|
|Cancer Centers of South Texas - HOAST||San Antonio, Texas 78229|