The Epigenetic Modification of Somatostatin Receptor-2 to Improve Therapeutic Outcome With Lutathera in Patients With Metastatic Neuroendocrine Tumours.

Who is this study for? Patients with metastatic neuroendocrine tumors
What treatments are being studied? ASTX727
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Be willing and able to provide written informed consent 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)

• Ki67 \< 55% (only patients with well differentiated grade 1-3 NETs will be included in the study as patients with poorly differentiated grade 3 NETs have a prognosis of less than 6 months)

• Progression or intolerance to first line therapy including somatostatin analogues

• ECOG Performance status 0 - 2

• No tumoural uptake on \[68Ga\]-DOTA-TATE or uptake less than background liver

⁃ Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions

⁃ Adequate organ function as outlined in the protocol

⁃ Women of childbearing potential must be willing to use a highly effective method of contraception as outlined in the protocol for the course of the study through 6 months after the last dose of Investigational Medicinal Product (IMP).

⁃ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subjects

⁃ Sexually active males must agree to use an adequate method of contraception as outlined in the protocol starting with the first dose of IMP through 6 months after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

Locations
Other Locations
United Kingdom
Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Rohini Sharma, Professor
rohini.sharma2@nhs.net
02083833170
Time Frame
Start Date: 2022-04-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 27
Treatments
Experimental: Treatment
Related Therapeutic Areas
Sponsors
Leads: Imperial College London
Collaborators: Advanced Accelerator Applications

This content was sourced from clinicaltrials.gov