Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 4

Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients

NCT05701241 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 4
Started
2023-06-28
Last updated
2024-06-14

Condition(s) studied

Gastroenteropancreatic Neuroendocrine Tumor

Investigational drug(s) / intervention(s)

Somatostatin analog →

Somatostatin analog: Somatostatin analog treatment every 4 weeks

Study summary

The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 World Health Organisation 2019 grade 1-2 GEP NET * Documented radiological disease progression on first-line SSA treatment at label dose or higher * 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 Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator Exclusion Criteria: * Indication for chemotherapy treatment of GEP NET in second-line * Presence of poorly differentiated grade 3 neuroendocrine carcinoma (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 screening, 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 * Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial

Primary outcome measure(s)

  • the difference in progression-free survival (PFS) in patients continuing or stopping second-line therapy with SSAs, as assessed by the blinded local investigator on cross-sectional imaging, according to RECIST 1.1 criteria per substudy — 18 months after start second-line treatment
    PFS
  • The difference in time to deterioration (TTD) in patients continuing or stopping second-line therapy with SSAs per substudy — 18 months after start second-line treatment
    TTD

Trial sites (19)

FacilityCityRegionStatus
AZ Klina Brasschaat Antwerp Recruiting
AZ Rivierenland Rumst Antwerp Active Not Recruiting
Ghent University Hospital Ghent East Flanders Active Not Recruiting
VITAZ Sint-Niklaas East-Flanders Recruiting
University Hospital Leuven Leuven Flemish Brabant Recruiting
Grand Hôpital de Charleroi Charleroi Hainaut Active Not Recruiting
AZ Monica Antwerp Belgium Not Yet Recruiting
GZA Antwerp Belgium Active Not Recruiting
Ziekenhuis Netwerk Antwerpen Antwerp Belgium Withdrawn
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
H.U.B. Brussels Belgium Active Not Recruiting
Antwerp University Hospital Edegem Belgium Recruiting
Centre Hospitalier Universitaire Sart Tilman Liège Belgium Active Not Recruiting
Rijnstate Arnhem Gelderland Recruiting
Maastricht UMC+ Maastricht Limburg Recruiting
Maxima Medisch Centrum Eindhoven North Brabant Active Not Recruiting
Amsterdam UMC Amsterdam North Holland Active Not Recruiting
UMC Groningen Groningen Netherlands Recruiting
Erasmus MC Rotterdam Netherlands Recruiting

More University Hospital, Antwerp trials in Belgium

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05701241 on ClinicalTrials.gov ↗ ← All trials in Belgium