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Spots Global Cancer Trial Database for Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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