التفاصيل البيبلوغرافية
| العنوان: |
Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET |
| المؤلفون: |
Singh, Simron, Ferone, Diego, Capdevila, Jaume, Chan, Jennifer Ang, de Herder, Wouter W., Halperin, Daniel, Mailman, Josh, Hellström, Lisa, Liedman, Hanna, Svedberg, Agneta, Tiberg, Fredrik |
| المصدر: |
Trials ; volume 25, issue 1 ; ISSN 1745-6215 |
| بيانات النشر: |
Springer Science and Business Media LLC |
| سنة النشر: |
2024 |
| مصطلحات موضوعية: |
Pharmacology (medical), Medicine (miscellaneous) |
| الوصف: |
Background The current standard of care (SoC) for the initial treatment of unresectable or metastatic well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) requires initiation of first-generation somatostatin receptor ligand (SRL) therapy, octreotide and lanreotide, which provide safe and efficacious tumour/symptom control in most patients. However, disease progression can occur with SoC SRL treatment and the optimal dose response of SRL remains unknown. Octreotide subcutaneous depot (CAM2029) is a novel, long-acting, high-exposure formulation that has shown greater bioavailability and improved administration than octreotide long-acting release (LAR) with a well-tolerated safety profile. Retrospective data have highlighted a potential benefit of high-exposure SRL for improved disease control in patients who did not adequately respond to the current SoC SRL treatment. This trial will investigate the efficacy and tolerability of CAM2029 compared to the current SoC, including octreotide LAR and lanreotide autogel (ATG). Methods SORENTO is a prospective, multicentre, randomised, active-controlled, open-label phase 3 trial aiming to demonstrate superiority of treatment with 20 mg octreotide subcutaneous depot (CAM2029) every 2 weeks (Q2W) compared to treatment with the Investigator’s choice of SRL therapy at standard doses for tumour control (octreotide LAR 30 mg or lanreotide ATG 120 mg every 4 weeks [Q4W]) as assessed by progression-free survival (PFS) in approximately 300 patients with unresectable/metastatic and well-differentiated GEP-NET. Upon confirmation of disease progression (determined by a Blinded Independent Review Committee [BIRC] and defined as per RECIST 1.1), patients may enter an open-label extension treatment period with once weekly dosing, to investigate the effects of higher frequency dosing. Overall survival follow-up will end a maximum of 2 years after primary analysis. The primary endpoint will be analysed after 194 confirmed PFS events. Discussion This is the ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1186/s13063-023-07834-8 |
| DOI: |
10.1186/s13063-023-07834-8.pdf |
| DOI: |
10.1186/s13063-023-07834-8/fulltext.html |
| الإتاحة: |
https://doi.org/10.1186/s13063-023-07834-8Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: |
edsbas.D169F480 |
| قاعدة البيانات: |
BASE |
