NCT01152346View on ClinicalTrials.gov

Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

May 31, 2013

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

Azacitidine for Injection

75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment

DRUG

Vidaza®

75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment

Trial Locations (13)

29609

CHU de Brest- Hôpital Morvan, Brest

31059

CHU Purpan, Toulouse

33308

Holy Cross Hospital, Fort Lauderdale

33604

Hôpital Haut-Lévêque, Pessac

37000

Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire, Tours

54511

Service d'hématologie et de médecine interne CHU de Nancy Hôpital de Brabois, Vandœuvre-lès-Nancy

69495

Centre Hospitalier Lyon Sud, Lyon

74374

CH Annecy, Pringy

92801

Pacific Cancer Medical Center Inc., Anaheim

92879

Wilshire Oncology Medical Group, Corona

93009

Service d'hématologie clinique Hôpital Avicenne, Bobigny

93720

California Cancer Associates, Fresno

06200

Hôpital Archet 1, Nice

Sponsors
All Listed Sponsors
lead

Bioniche Pharma USA LLC

INDUSTRY

NCT01152346 - Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients | Biotech Hunter | Biotech Hunter