At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ASTX727 (drug), Lutathera (radiation)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- ASTX727 — drug: Cedazuridine 100mg + 35mg decitabine · Lutathera — radiation: Peptide receptor radionuclide therapy (PRRT)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 27
- Started
- 2022-04-25
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for neuroendocrine tumors
- • Phase1 - 27 participants
- • 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
Who can take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with neuroendocrine tumors
Where?
- • London - Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Be willing and able to provide written agreement to take part for the trial.
- ✓Be aged 18 or over at the day of signing consent
- ✓Histologic or cytologic confirmed diagnosis of neuroendocrine tumour
- ✓Have archival tissue block available or willing to have fresh tissue biopsy if blocks not available
- ✓Have disease that can be readily biopsied by ultrasound guidance (n=5)
Who cannot take part
- ✗Previous treatment with either study medication and/or known hypersensitivity to the study medication
- ✗Serious concurrent medical illness, including serious active infection
- ✗History of organ transplant
- ✗Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local...
- ✗Has a known history of active Bacillus Tuberculosis (TB).
See the full criteria
Where Is This Study? (1 UK site)
Hammersmith Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Rohini Sharma, Professor
Sponsor contactCONTACT
