12
Participants
Start Date
December 14, 2022
Primary Completion Date
June 30, 2025
Study Completion Date
December 5, 2025
Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET
Fixed dose treatment cycles 1 to 6. Cycle 1 is monotherapy, cycles 2 to 6 combination therapy with defactinib.
Defactinib
"Defactinib treatment will commence with at the starting dose (dose level 1) from cycle 2 to 6.~Dose escalation/de-escalation will proceed based on the MTD determination.~Dose Level 1: 200mg Defactinib twice daily (starting dose level)~Dose Level 2: 400mg defactinib twice daily~Dose Level -1: 200mg Defactinib daily"
RECRUITING
Prince of Wales Hospital, Sydney
RECRUITING
Royal Prince Alfred Hospital, Sydney
RECRUITING
Concord Repatriation and General Hospital, Sydney
RECRUITING
Westmead Hospital, Westmead
RECRUITING
Nepean Hospital, Sydney
Lead Sponsor
The University of New South Wales
OTHER
Australian National University
OTHER
Clinical Hub for Interventional Research (CHOIR)
OTHER_GOV