P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025

P4, N=3, Completed, Sheba Medical Center | Unknown status --> Completed | N=10 --> 3

We treated cells derived from 23 NF-PitNETs with ITF2984, and a subset of them with octreotide, pasireotide (SRLs with high affinity for SSTR2 or 5, respectively), or cabergoline (DRD2 agonist) and we measured cell proliferation and apoptosis. In our model, SSTR3 expression levels did not correlate with ITF2984 antiproliferative nor proapoptotic effects. In conclusion, our data support a possible use of ITF2984 in the pharmacological treatment of NF-PitNET.

P=N/A, N=151, Completed, RECORDATI GROUP | Recruiting --> Completed | Trial completion date: May 2024 --> Jul 2023

Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks...Increasing age, HbA1c, and FPG and pre-diabetes/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment.

P=N/A, N=129, Active, not recruiting, Ipsen | Recruiting --> Active, not recruiting | N=210 --> 129

Pasireotide is effective and safe in the long-term. Hyperglycemia is a common event and is manageable even without insulin treatment.

The vast majority of patients with acromegaly now have successful disease control with a multimodal approach. They reached biochemical control sooner in the most recent half of the study period. Future work should focus on those patients who are still uncontrolled and on the sequelae of the disease.

P=N/A, N=70, Recruiting, Mario Negri Institute for Pharmacological Research | Not yet recruiting --> Recruiting

P2, N=10, Recruiting, Memorial Sloan Kettering Cancer Center

Surgical resection of the associated tumour is curative in most NICTH cases. When the tumour is unresectable, moderate-dose glucocorticoids, low-dose glucocorticoids in combination with recombinant growth hormone, and pasireotide are medical therapies with promising results in controlling NICTH.

Tumor shrinkage was observed in 6 out of 7 evaluated responders, with no cases of size increase during the long-term follow-up. Pas-LAR is effective and safe and the early identification of responders is possible just after the first administration.

P2, N=6, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | N=217 --> 6 | Trial completion date: Sep 2023 --> Feb 2024 | Suspended --> Terminated | Trial primary completion date: Jul 2023 --> Feb 2024; No more experimental drugs available

P2/3, N=71, Active, not recruiting, Camurus AB | Recruiting --> Active, not recruiting

UPR markers in FPitNETs are implicated as dominant A-UPR but blunted T-UPR. KIRA8, enhanced with octreotide, unbalances UPR, leading to anti-tumor effects. Targeting IRE1α may provide a novel strategy to treat PitNETs.

P3, N=332, Active, not recruiting, Camurus AB | Recruiting --> Active, not recruiting

This is the first trial investigating the efficacy of CAM2029 versus SoC SRL therapy using a head-to-head, superiority trial design. It is expected to be the first trial to investigate the efficacy of increased dosing frequency of a high-exposure SRL. A BIRC will limit bias and measurement variability and ensure high-quality efficacy data. Additionally, inclusion of patients with well-differentiated Grade 3 NET may elucidate treatment strategies for this rarely investigated patient population.

In real-life settings, PAS-LAR significantly decreases symptoms, IGF-1 levels, and the size of adenoma in patients with acromegaly resistant to SRLs. Beneficial effects may occur early after the first injection.

The long-acting SSAs octreotide long-acting release and lanreotide are commonly used in the first-line metastatic setting because of their tolerable side effect profile...A key question in management of patients with gastroenteropancreatic and lung NETs is the sequencing of Lu-DOTATATE in relation to other systemic treatments (such as everolimus) or liver-directed therapies. This question is particularly complicated given the heterogeneity of NETs and the near absence of randomized trials comparing active treatment options. This state-of-the-art review examines the evidence supporting use of somatostatin-receptor-targeted treatments within the larger landscape of NET therapy and offers insights regarding optimal patient selection, assessment of benefit versus risk, and treatment sequencing.

P2, N=72, Recruiting, RECORDATI GROUP | Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> Jan 2024

LAN plus TMZ is a treatment option for patients with progressive GEP-NET with more aggressive biological profile showing a manageable safety profile.

P=N/A, N=70, Not yet recruiting, Mario Negri Institute for Pharmacological Research

Parallel incubations with 10 nM pasireotide were also carried out...This first study on a novel somatostatin receptor 5-preferring ligand indicates that HTL0030310 can inhibit hormonal secretion in human ACTH- and GH-secreting pituitary adenomas. These findings suggest a potential new avenue for somatostatin ligands in the treatment of Cushing's disease and acromegaly.

P1, N=30, Active, not recruiting, Debiopharm International SA | Recruiting --> Active, not recruiting | Phase classification: P1b --> P1 | Trial completion date: Jun 2025 --> Dec 2024 | Trial primary completion date: May 2025 --> Nov 2024

P=N/A, N=411, Completed, Changhai Hospital

P1, N=56, Completed, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting --> Completed

Pancreatic neuroendocrine tumor could lead to malignant hypercalcemia; secretion of PTHrP is the most common cause, and signs and symptoms are usually milder than paraneoplastic syndrome due to hematologic and solid tumor. Generally, survival is better; however, its treatment is challenging, and primary debulking surgery is often required. A team approach to management is important at all points.

Preoperative octreotide treatment for the purpose of reducing excessive thyroid hormones may not enhance surgical outcomes, and the duration of octreotide treatment needs to be extended to fully benefit from the tumor-shrinking effects of SSAs.

Long-acting SSAs are an effective and safe initial therapy of patients with well differentiated NET, allowing tumor growth as well as symptoms control for long-time in selected patients.

After further oncology evaluation, long-acting octreotide acetate was initiated, and she continues close follow up...Fig 1c. Histology slide of rectal polyp 400x H&E showing uniform round nuclei with finely stippled “salt and pepper” chromatin consistent with NET.

Currently, the patient is treated with monthly octreotide LAR...She was initially treated with bromocriptine and then underwent TSS without achieving remission...Modern NGS-based genetic testing is an effective method for identifying such cases. Precise molecular testing has an impact on the timely diagnosis of these lesions, as well as on their prognosis and the need for genetic counseling.

Octreotide LAR dosing above the label-maximum dose is common and IR rescue dosing appears to be underutilized.

P3, N=220, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.

P1b, N=30, Recruiting, Debiopharm International SA | Trial completion date: Feb 2025 --> Jun 2025 | Trial primary completion date: Jan 2025 --> May 2025

P2, N=20, Completed, Assistance Publique Hopitaux De Marseille | Unknown status --> Completed

The questions regarded the use of long-acting octreotide and lanreotide in the following settings: functioning and non-functioning NET refractory to label dose, first-line metastatic pulmonary NET, combination with other therapy with an antiproliferative intent, maintenance in NET responding to other therapies, adjuvant treatment, Ki-67-related cut-off, somatostatin receptor imaging, safety, and feasibility...Mention of such specific issues by the main European guidelines (ENETS, European Neuroendocrine Tumor Society, and ESMO, European Society for Medical Oncology) was explored and their position reported. However, different clinical decisions on single patients could be made if the case is carefully discussed within a NET-dedicated multidisciplinary team.

In scarred lesions, alternative resection strategies including free-hand EFTR with robust closure techniques may be considered. Improvements in OTSC design to prevent early dislodgement need to be considered in the future iterations of GD-FTRD.

He was then started on octreotide 50 mcg TID and eventually transitioned to Sandostatin depot 20 mg intergluteal injection every 4 weeks... Acromegaly is often missed due to the insidious onset of physical changes that are observed. Literature review reveals only two other cases of acromegaly related NICM resulting in cardiogenic shock, in which only one patient received an emergent heart transplant. When recognized early, patients can be treated surgically and or/medically before irreversible changes occur.

Change to multiple small meals, addition of cornstarch to diet, continuous blood glucose monitoring (CGM), diazoxide (70 mg oral, three times a day), and monthly octreotide LAR (30 mg) has allowed the patient to avoid hypoglycemia... Our study highlights that in adults with non-insulinoma pancreatogenous hypoglycemia, genetic causes of HH should be considered in the differential diagnosis.*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference.