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Brief Title: Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients
Official Title: A Multi-Center Relative Bioavailability Study of Azacitidine 75 mg/m2 Subcutaneous Injection In Myelodysplastic Syndrome Patients Under Fasting Conditions
Study ID: NCT01152346
Brief Summary: The purpose of the study is to determine the bioavailability of Azacitidine for Injection relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated statistically to determine if the products meet bioequivalence criteria.
Detailed Description: This study is an open label, multi-center randomized, single dose, two-treatment, two-period, two-sequence, two-way cross-over, relative bioavailability study of Azacitidine for Injection for suspension use manufactured for Bioniche Pharma USA LLC compared with Vidaza® manufactured by Celgene Corporation in MDS patients under fasting conditions. Patients who are on a stable 75 mg/m2 dose of Vidaza will be randomized to study drug sequence Azacitidine on C1D1/ Vidaza® on C2D1 or Vidaza® on C1D1 / Azacitidine on C2D1. Randomization will be in a 2:2 ratio. Thirty-six (36) patients will be enrolled to ensure 28 evaluable patients. Patients will not be blinded to their treatment assignment. After randomization, fasted patients will receive 1 dose of assigned study drug (either Azacitidine for Injection or Vidaza®) subcutaneously at a dose of 75 mg/m2 on C1D1. On Days 2-7, they will receive their normal Vidaza® treatment. Following a 21 day rest period, patients will cross over to receive the alternate treatment on C2D1 followed by their normal Vidaza®) treatment on Cycle 2 Days 2-7. The Final Patient Visit will be conducted 7 days following the last dose of Vidaza®. The total duration of the study for each patient will be up to 56 days including the Screening period and Post Study Visit.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pacific Cancer Medical Center Inc., Anaheim, California, United States
Wilshire Oncology Medical Group, Corona, California, United States
California Cancer Associates, Fresno, California, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Service d'hématologie clinique Hôpital Avicenne, Bobigny cedex, , France
CHU de Brest- Hôpital Morvan, Brest, , France
Centre Hospitalier Lyon Sud, Lyon, , France
Hôpital Archet 1, Nice, , France
Hôpital Haut-Lévêque, Pessac, , France
CH Annecy, Pringy, , France
CHU Purpan, Toulouse, , France
Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire, Tours, , France
Service d'hématologie et de médecine interne CHU de Nancy Hôpital de Brabois, Vandoeuvre, , France
Name: Pierre FENAUX, MD Professor
Affiliation: Service d'hématologie clinique- Hôpital Avicenne
Role: STUDY_CHAIR
Name: Emmanuel GYAN, MD
Affiliation: Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire-Hôpital Bretonneau
Role: PRINCIPAL_INVESTIGATOR
Name: Agnès-Paule GUERCI-BRESLER, MD
Affiliation: Service d'hématologie et de médecine interne-Hôpital de Brabois
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Richard Eveillard, MD
Affiliation: CHU de Brest- Hôpital Morvan
Role: PRINCIPAL_INVESTIGATOR
Name: Odile BEYNE-RAUZY, MD Professor
Affiliation: University Hospital, Toulouse
Role: PRINCIPAL_INVESTIGATOR
Name: Laurence LEGROS, MD
Affiliation: Hôpital Archet 1
Role: PRINCIPAL_INVESTIGATOR
Name: Mauricette MICHALLET, MD Professor
Affiliation: Hôpital Edouard Herriot
Role: PRINCIPAL_INVESTIGATOR
Name: Krimo Bouabdallah, MD
Affiliation: Hôpital Haut-Lévêque
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal Cony-Makhoul, MD
Affiliation: CH Annecy
Role: PRINCIPAL_INVESTIGATOR
Name: Manjesh Lingamurthy, MD
Affiliation: Holy Cross Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Hager, MD
Affiliation: California Cancer Associates
Role: PRINCIPAL_INVESTIGATOR
Name: Misagh Karimi, MD
Affiliation: Wilshire Oncology Medical Group
Role: PRINCIPAL_INVESTIGATOR
Name: Veena Charu, MD
Affiliation: Pacific Cancer Medical Center Inc.
Role: PRINCIPAL_INVESTIGATOR