Clinical Trials
CELESTIAL
Combined evaluation of epigenetic and sensitising therapy in AML and MDS.
A phase I study of oral decitabine and cedazuridine (ASTX727) in combination with defactinib (VS-6063) as therapy of myelodysplastic syndromes and low-blast acute myeloid leukaemia
CELESTIAL Trial
Project Status
Current
Indication
High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukaemia (AML), and Chronic Myelomonocytic Leukaemia (CMML)
Goal
The goal of this project is to improve treatment for people living with high risk MDS by initially determining if Inqovi®, a combination of two drugs called decitabine and cedazuridine, can be safely given with a new potential treatment called defactinib.
Inqovi®, also called ASTX727 is approved for use by the Australian Therapeutics Goods Administration (TGA) as treatment for MDS. Defactinib is an experimental treatment. This means it is not an approved treatment for MDS in Australia, however, so far it has been given to over 625 patients in clinical trials across the world. ASTX727 is an oral form of decitabine, (which is in the same class of hypomethylation agents as azacitidine) combined with another drug, cedazuridine that slows the breakdown of the drug in the liver so more of the drug is available to act on the body’s tissues.
These potential new treatments when given together are not approved treatments for MDS/CMML/AML in Australia. This means this combination therapy is experimental; therefore this research is testing the safety and effects of this treatment combination in this clinical trial.
Method
All eligible participants will receive active treatment, there is no placebo. Participants will take the ASTX727 as a single agent for the first treatment cycle, and from Cycle 2 onwards defactinib treatment will also be taken.
Both drugs are tablets, participants take at home. The trial includes 6 months of study visits during treatment, followed by 24 months of follow-up.
CHOIR manages the clinical operations of the CELESTIAL trial and is currently collaborating with other researchers from the Lowy Cancer Research Centre, University of New South Wales (UNSW) Sydney and The Australian National University (ANU).
The trial is funded by the Medical Research Future Fund (MRFF) with the two study drugs for this trial being provided by manufacturing partners Taiho Oncology (formerly Astex Pharmaceuticals) for Inqovi® (ASTX727) and Verastem Oncology for defactinib.
This Phase I trial is being conducted over 5 years in NSW, at Prince of Wales, Concord, Nepean, Westmead and Royal Prince Alfred Hospitals.
Contact
Senior Trial Manager
Jo-Fan Lin
Email: celestial.jcsmr@anu.edu.au