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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic

In brief

The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.

Key facts

Study ID

NCT00761722

Run by

Celgene

People needed

31

Starts

2008-08-12

Expected to finish

2016-04-07

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Diagnosis of MDS or CMML
• Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
• ECOG Performance Status 0-2
• Use of acceptable birth control
• Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
• Serum bicarbonate greater than or equal to 20 mEq/L
• Platelet count greater than or equal to 25,000/uL
• Hemoglobin greater than or equal to 500/uL
• Signed informed consent

You may not qualify if…

• Diagnosis of acute promyelocytic leukemia
• Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
• Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
• Hypersensitivity to azacitidine or mannitol
• Active, uncontrolled infection
• Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
• Known or active HIV, viral hepatitis B or C
• Breastfeeding or pregnant females
• Current or uncontrolled cardiac disease

Where it is running

• California Cancer Care Inc — Greenbrae, California, United States
• Main Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Northwest Cancer Specialists, P.C. — Albuquerque, New Mexico, United States
• Willamette Valley Cancer Institute — Springfield, Oregon, United States
• University of Texas- MD Anderson — Houston, Texas, United States
• Hematology and Oncology Assoc. of South Texas — San Antonio, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Yakima Valley Memorial Hospital/ North Star Lodge — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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