40
Participants
Start Date
May 18, 2018
Primary Completion Date
September 15, 2020
Study Completion Date
September 21, 2021
Azacitidine
75mg/m2 per day for 7 days of each 28 day cycle. Cycles 1-6
CC-486
100 mg BID for the first 21 days of each 28-day treatment cycle (cycles 7-8). The dose should be increased from cycle 9 onwards to 150mg BID for the first 21 days of each 28-day treatment cycle (cycles 9-12) in the absence of Grade 3 or 4 AE. If 2 or more cycles are tolerated at this dose, further increments are permitted for patients with Stable Disease or if clinically indicated in consultation with the coordinating investigator as per the study dose modification schedule.
Gosford and Wyong Hospitals, Sydney
Prince of Wales Hospital, Sydney
Royal North Shore Hospital, Sydney
Blacktown Hospital, Sydney
Liverpool Hospital, Sydney
St George Hospital, Sydney
Calvary Mater Newcastle, Newcastle
Wollongong Hospital, Wollongong
Nepean Hospital, Penrith
Royal Prince Alfred Hospital, Sydney
St Vincent's hospital, Sydney
Lead Sponsor
Collaborators (1)
Celgene
INDUSTRY
Kirby Institute
OTHER_GOV