Crossover Study to Evaluate the Bioequivalence and Food Effect Bioavailability of Oral Azacitidine Tablets in Adult Cancer Subjects
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases:
Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension
This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.
Study phase: I
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Age: 18 and older
Gender: Males and females
Diagnosis: MDS, AML, MM, NHL, HL, Metastatic or inoperable solid tumors (except gastrointestinal tumors or tumors that originated or metastasized to the liver) for which no standard treatment exists, or have progressed or recurred following prior therapy.
Primary disease category: Cancer
Sponsor: Celgene Corporation
Projected enrollment dates: April 2017 to December 2017
Official study title: A Phase 1 Open-Label, Multicenter, Randomized, 2-Period, Crossover Study to Evaluate the Bioequivalence and Food Effect Bioavailability of CC-486 (Oral Azacitidine) Tablets in Adult Cancer Subjects
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT02223052