Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 14, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

December 5, 2025

Conditions
Myelodysplastic SyndromesChronic Myelomonocytic LeukemiaAcute Myeloid Leukemia
Interventions
DRUG

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.

DRUG

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"

Trial Locations (5)

2031

RECRUITING

Prince of Wales Hospital, Sydney

2050

RECRUITING

Royal Prince Alfred Hospital, Sydney

2139

RECRUITING

Concord Repatriation and General Hospital, Sydney

2145

RECRUITING

Westmead Hospital, Westmead

2747

RECRUITING

Nepean Hospital, Sydney

All Listed Sponsors
collaborator

The University of New South Wales

OTHER

collaborator

Australian National University

OTHER

lead

Clinical Hub for Interventional Research (CHOIR)

OTHER_GOV