Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients (SAUNA trial)

Phase 1

Recruiting

• Conditions: neuroendocrine tumours; MedDRA version: 20.0Level: PTClassification code: 10077559Term: Gastroenteropancreatic neuroendocrine tumour disease Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10077560Term: Gastroenteropancreatic neuroendocrine tumor disease Class: 10029104; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 21.0Level: PTClassification code: 10052399Term: Neuroendocrine tumour Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10067517Term: Pancreatic neuroendocrine tumour Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]; MedDRA version: 21.0Level: LLTClassification code: 10062476Term: Neuroendocrine tumor Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10067518Term: Pancreatic neuroendocrine tumor Class: 10029104

• Registration Number: CTIS2022-502703-30-00
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Age =18 years, Written informed consent prior to any study-related procedures, Eastern Cooperative Oncology Group (ECOG) performance status = 2, Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated WHO 2019 grade 1-2 GEP NET, Documented radiological disease progression on first-line SSA treatment, For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator, For PRRT substudy: indication to start with PRRT with 177Lu-DOTATATE as second-line therapy, according to local investigator

Exclusion Criteria

Indication for chemotherapy treatment of GEP NET in second-line, Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial, Presence of poorly differentiated grade 3 NEC, well-differentiated grade 3 NET or rapidly progressive NET, Prior treatment with everolimus, sunitinib or PRRT, Contra-indication, proven allergy or other indication than functional NET for the use of a SSA, Patient showing progressive disease while being on a lower than the registered dose, Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome, Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET, Concurrent anti-cancer treatment in another investigational trial, Any abnormal findings at baseline, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified