Oral azacitidine bioequivalence study in patients with solid tumor or hematologic malignancies

Investigator: Swaminathan Iyer, MD

Study Coordinator: Ramon Guardiola

Status: Enrolling

ClinicalTrials.gov Number: NCT02223052

Phone: 713.441.3958

IRB Number: Pro00012503


An oral formulation of azacitidine (CC-486) has been developed and is currently in clinical trials for the treatment of hematologic and solid tumor malignancies. The oral formulation will provide an opportunity to deliver the drug daily over a more prolonged schedule than can be practically achieved with parenteral therapy. In this study, the bioequivalence of oral azacitidine when administered once daily as one 300 mg tablet relative to two 150 mg tablets will be tested in adult cancer patients with hematologic malignancies or various solid tumor types. If bioequivalence is shown between formulations, the one 300 mg tablet would be more convenient to treat patients and will be used for further development of oral azacitidine in hematologic and solid tumor cancers.
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