Trial reportCancer chemotherapy and pharmacology2013
Safety, tolerability, pharmacokinetics, and pharmacodynamics of a long-acting release (LAR) formulation of pasireotide (SOM230) in patients with gastroenteropancreatic neuroendocrine tumors: results from a randomized, multicenter, open-label, phase I study.
Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 43 citations in OpenAlex.
- Trial
- Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors.Endocrine-related cancer · 2015Trial
- Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement.Endocrinology and metabolism (Seoul, Korea) · 2019Review
- Carcinoid-syndrome: recent advances, current status and controversies.Current opinion in endocrinology, diabetes, and obesity · 2018Review
- A systematic review and meta-analysis of gastrointestinal events associated with nonoperative therapies for neuroendocrine tumors.OncoTargets and therapy · 2018Review
- The Treatment Landscape and New Opportunities of Molecular Targeted Therapies in Gastroenteropancreatic Neuroendocrine Tumors.Targeted oncology · 2017Review
- Article
- Treatment of symptomatic neuroendocrine tumor syndromes: recent advances and controversies.Expert opinion on pharmacotherapy · 2016Review
- Phase I trial of combination of FOLFIRI and pasireotide, a somatostatin analogue, in advanced gastrointestinal malignancies.Investigational new drugs · 2015Article
- Somatostatin analogs for gastric carcinoids: For many, but not all.World journal of gastroenterology · 2015Review
- AACE/ACE disease state clinical review: diagnosis and management of midgut carcinoids.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2015Review
- Treatment of neuroendocrine tumors: new recommendations based on the CLARINET study.Contemporary oncology (Poznan, Poland) · 2015Review
- Clinical use of pasireotide for Cushing's disease in adults.Therapeutics and clinical risk management · 2015Review
- GIPR expression in gastric and duodenal neuroendocrine tumors.The Journal of surgical research · 2014Article
- Expressions of Somatostatin Receptor Subtypes (SSTR-1, 2, 3, 4 and 5) in Neuroblastic Tumors; Special Reference to Clinicopathological Correlations with International Neuroblastoma Pathology Classification and Outcomes.Acta histochemica et cytochemica · 2014Article
- PI3K-AKT-mTOR-signaling and beyond: the complex network in gastroenteropancreatic neuroendocrine neoplasms.Theranostics · 2014Review
- Metastatic type 1 gastric carcinoid: a real threat or just a myth?World journal of gastroenterology · 2013Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePasireotide (SOM230), a novel multireceptor ligand somatostatin analog (SSA), binds with high affinity to four of the five somatostatin receptor subtypes (sst1-3, 5). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of pasireotide long-acting release (LAR) formulation in patients with advanced gastroenteropancreatic neuroendocrine tumor (GEP NET) refractory to other SSAs.
methodsIn this randomized, multicenter, open-label, phase II study, patients with biopsy-proven primary or metastatic GEP NET refractory to available SSAs were randomly assigned 1:1:1 to receive pasireotide LAR by deep intragluteal injection at a dose of 20, 40, or 60 mg once every 28 days for 3 months.
resultsForty-two patients received pasireotide LAR. Adverse events were reported by 34 (81 %) patients, with the most frequently reported including diarrhea, fatigue, abdominal pain, and nausea. Mean fasting glucose levels were increased compared with baseline at all points throughout the study. After the third injection of pasireotide LAR, the median trough plasma concentrations on day 84 were 4.82, 12.0, and 19.7 ng/mL in the 20-, 40-, and 60-mg treatment groups, respectively. Drug accumulation was limited for each dose based on the increase in trough concentrations after the first to third injections (accumulation ratios were approximately 1 from all dose levels).
conclusionsThis study demonstrated that a new, once-monthly, intramuscular LAR formulation of pasireotide was well tolerated in patients with advanced GEP NET. Steady state levels of plasma pasireotide were achieved after three injections.
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