Patients entered into the study will receive ASTX727 orally for 5 days, prior to receiving Lutathera treatment on Day 8, to determine whether pre-treatment with ASTX727 results in re-expression of somatostatin receptor-2 in patients with metastatic neuroendocrine tumours. The study will use \[68Ga\]-DOTA-TATE PET to image epigenetic modification of the receptor locus.
Patients with neuroendocrine tumours (NET) who are found to be eligible will receive up to 4 doses of Lutathera on this trial. All participants will receive ASTX727 orally (cedazuridine 100mg + 35mg decitabine) Days 0-5 prior to receiving Lutathera Day 8 +/- 2days. Each cycle will be repeated every 2 months for 4 cycles unless unacceptable toxicity, progression of disease or withdrawal of patients' consent. Restaging will occur after 2 cycles of Lutathera and at the end of treatment. Patients will be followed 3 monthly until disease progression, death or withdrawal of patients' consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Hammersmith Hospital
London, London, City of, United Kingdom
RECRUITINGTo determine whether pre-treatment with ASTX727 results in re-expression of SSTR2 in patients with metastatic NETs, using [68Ga]-DOTA-TATE to image epigenetic modification of the SSTR2 locus allowing subsequent treatment with Lutathera
This outcome will be assessed using a specific PET scan
Time frame: Through study completion, an average of 1 year
To assess tolerability of combination therapy
This outcome will be assessed using CTCAE v5.0
Time frame: Through study completion, an average of 1 year
To assess response to treatment using conventional imaging
This outcome will be assessed using standard of care CT scans
Time frame: Through study completion, an average of 1 year
To assess patients quality of life during treatment
This will be assessed using standardised quality of life questionnaires, which will be given to the patients
Time frame: Through study completion, an average of 1 year
To assess progression free survival
This will be the time until patients show progressive disease on their routine CT scans
Time frame: Through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.