octreotide acetate

P3, N=288, Active, not recruiting, RayzeBio, Inc. | Recruiting --> Active, not recruiting

P2, N=135, Not yet recruiting, European Organisation for Research and Treatment of Cancer - EORTC

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

P3, N=427, Active, not recruiting, National Cancer Institute (NCI)

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.

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.

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

P1, N=14, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P3, N=288, Recruiting, RayzeBio, Inc.

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

P3, N=288, Recruiting, RayzeBio, Inc. | Phase classification: P1b --> P3

P3, N=222, Active, not recruiting, Advanced Accelerator Applications | Trial completion date: Jul 2027 --> Oct 2027

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

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.

P1b, N=288, Recruiting, RayzeBio, Inc. | N=218 --> 288

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.

P3, N=222, Active, not recruiting, Advanced Accelerator Applications | Trial primary completion date: Nov 2023 --> Jul 2023

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.

Outcomes were: demographic characteristics; treatment frequency by line of treatment (LOT) and changes between LOTs (Sankey plot); treatment persistence for first LOT (LOT 1) monotherapies (Kaplan-Meier estimator); and treatment up-/downtitration (=30% dose change, evaluated for octreotide long-acting release [OCT] and lanreotide depot [LAN])...Other LOT 1 classes were DAs (cabergoline; 34.5%) and GHRAs (pegvisomant; 10.5%). Only 7 patients received second-generation SRL pasireotide and no patients received oral octreotide in LOT 1...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*

Key inclusion criteria included a biochemical and clinical diagnosis of acromegaly due to a pituitary adenoma with persistent or recurrent disease, treatment with a stable dose of octreotide long-acting release or lanreotide Autogel for at least 3 months as monotherapy, and controlled disease with IGF-1 =1 x upper limit of normal (ULN). Key exclusion criteria included GH =2.5 µg/L at screening, pituitary surgery within 6 months of screening, prior pituitary irradiation, and recent treatment with pasireotide, pegvisomant, or dopamine agonists...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*

First line medical therapy consists of first-generation injectable somatostatin receptor ligands (SRL) (octreotide LAR, lanreotide autogel)...If IGF-1 levels do not normalize, pasireotide or pegvisomant can be tried...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*

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.

P1b, N=218, Recruiting, RayzeBio, Inc. | Active, not recruiting --> Recruiting

The other three declined surgery for the time being and were started on monthly long-acting Octreotide...Her cabergoline dose was increased and was referred for Trans-sphenoidal surgery. Discussion : The literature review revealed a very rare synchronous presentation of acromegaly and FSH-secreting pituitary adenoma...Up to 25% of GH adenomas co-secrete prolactin. The Third Type occurs due to Primitive acidophilic stem cell adenomas with dual hormone secretion from a single cell.

Long-acting octreotide and lanreotide do not interfere with the uptake of [Lu]Lu-HA-DOTATATE in tumour lesions 24 h post-injection. Uptake in healthy liver parenchyma significantly decreases after lanreotide administration prior to PRRT, while uptake in healthy spleen tissue significantly decreases with both octreotide and lanreotide administration.

P1b, N=218, Active, not recruiting, RayzeBio, Inc. | Recruiting --> Active, not recruiting

Clinical efficacy/effectiveness, safety, and HRQoL outcomes in adults with acromegaly were similar and costs lower with EDIs versus standard regimens. Physicians may consider acromegaly treatment at EDIs, especially for patients with good disease control.

Lu-177-DOTATATE 7,4 GBq every 8 weeks for 4 cycles, together with octreotide LAR 30 mg monthly, demonstrated a median PFS of 28,4 months compared to 8,5 months for octreotide LAR 60 mg monthly. A second pivotal study COMPETE is currently in progress, comparing no carrier-added (n.c.a.) Lu-177-DOTATOC to the m-TOR inhibitor Everolimus in both GE-NETs and PNETs...Antagonists have a higher tumor binding to receptors than agonists, opening up the potential indications for SSTR2 targeting to tumors which have a relatively lower expression of SSTR2 compared to NET such as small cell lung cancer, hepatocellular carcinoma and breast cancer. In addition to Lu-177, radioisotopes with different radiation properties such as Tb-161 and the α-emitter Ac-225 are being developed which have the potential to improve treatment efficacy across the range of G1 to G3 NETs.

Postoperatively, the patient received combined chemotherapy of 5-fluorouracil with interferon for six months and since has remained asymptomatic. The patient received somatostatin analogue therapy followed by long-acting release octreotide analogue therapy (30 mg/month) showing a partial improvement of relevant biomarkers. Two years later, carcinoid syndrome symptoms reappeared and due to the tumors expression of somatostatin receptors the patient received peptide receptor radionuclide therapy with 177Lu-DOTATATE that resulted in both clinical and biochemical improvements.

P3, N=222, Active, not recruiting, Advanced Accelerator Applications | Recruiting --> Active, not recruiting | Trial completion date: Oct 2027 --> Jul 2027

Quantitative tumor burden based on [ Ga]Ga-DOTA-NOC PET/CT was correlated with OS and PFS in patients with non-functional NETs with a ki-67 index of ≤ 10% who received octreotide LAR. Calculating normalized and liver normalized doses may help in selecting the starting dose of octreotide LAR.

Test with short-acting octreotide was performed in 24 patients and with long-acting octreotide in 12 patients: 15 and 4 patients, respectively, showed full thyroid hormone normalization...The most effective treatment is neurosurgery. Possible early-postoperative TSH levels model is suggested to predict relapses of TSH-PAs.