Somatuline Depot (lanreotide prolonged-release subcutaneous)

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

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

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

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.

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

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

Supported by a solid rationale, the trial has the potential to generate milestone data about the synergistic effects of cabozantinib plus lanreotide in a group of NET patients with relatively aggressive disease and limited therapeutic options.

The lack of change in patient's perceptions of the disease, treatment, and supportive care information provided over the first 6 months of LAN treatment may suggest that physicians provided adequate information at the treatment initiation.

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

Nurses strongly preferred the user experience of the Somatuline Autogel syringe over the Lanreotide Pharmathen syringe. "Ease of use" and "comfortable to handle" were the most important syringe attributes, and performance rating was significantly higher with Somatuline Autogel versus Lanreotide Pharmathen syringe for all but one attribute.

P=N/A, N=95, Recruiting, Asan Medical Center | Trial primary completion date: Jan 2023 --> Jan 2024

Standard starting dose of lanreotide 120 mg every 28 days was used in 66 patients...Overall, our findings were in keeping with current guidelines. It will be interesting to assess how clinical practice evolves in the future and to determine the role of dose escalation for disease control.

Most patients did not experience anxiety prior to their most recent injection and acknowledged that thanks to their treatment they had a good quality of life despite their disease. Most strongly agreed that the PSP met their medical needs, which highlights the valuable service that LAN PSPs provide for patients with NETs.

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

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.*

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.*

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.*

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

P1/2, N=49, Recruiting, National Health Research Institutes, Taiwan | Not yet recruiting --> Recruiting

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

Given the somatostatin imaging positivity of both pancreatic mass and lymph nodes, the patient was started on long-acting somatostatin analogs (somatuline Autogel120 mg administered every 28 days)...Pancreatic metastasis of HCC are rare, with but a few cases described in the literature. To our knowledge, this is the first case of a pancreatic metastasis as the initial presentation of an HCC recurrence 16 years after liver transplant and exhibiting SSTRs expression.

P3, N=43, Completed, Ipsen | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Jan 2023

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.

This study showed that LAN/TMZ combination has promising efficacy in progressive T-NETs, and was well tolerated. Larger studies are warranted to support the clinical benefits of LAN/TMZ in patients with T-NETs.

P1b, N=30, Recruiting, Debiopharm International SA | Trial completion date: Jul 2024 --> Feb 2025 | Trial primary completion date: Jun 2024 --> Jan 2025

P1b, N=218, Recruiting, RayzeBio, Inc.

P1b, N=30, Recruiting, Debiopharm International SA | Not yet recruiting --> Recruiting

P1b, N=30, Not yet recruiting, Debiopharm International SA | Trial completion date: Dec 2024 --> Jul 2024

P1b, N=30, Not yet recruiting, Debiopharm International SA

In uncontrolled patients with acromegaly, a trial with oral estrogen can be an option for young women. Oral estrogen was well tolerated, but the somatotropinoma that presented ER-α expression was the only somatotropinoma that presented growth during treatment.

Background and Objectives: Long-acting somatostatin analogues (SSA) (octreotide LAR and lanreotide Autogel) are recommended as first line treatment of locally advanced or metastatic well-differentiated neuroendocrine tumors (NETs) with a good expression of somatostatin receptor (SSTR). The method of administration of long-acting SSA injection performed by professional medical staff vs. self-injection of the drug may significantly affect the risk of NET progression. The unequivocal confirmation of such a relationship requires further observation.

P3, N=43, Active, not recruiting, Ipsen | Recruiting --> Active, not recruiting

P2, N=40, Recruiting, Antonio Fojo | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2023

SPINET, the largest prospective study to date with a somatostatin analog in SSTR-positive BP_NETs, suggests LAN 120 mg could be an appropriate treatment option, especially for TC. This study is funded by Ipsen.

P3, N=77, Terminated, Ipsen | Completed --> Terminated; National Comprehensive Cancer Network & European Neuroendocrine Tumor Society guidelines (2015/2016) led to prescription of somatostatin analogues (SSAs) in this setting, thereby limiting recruitment.

P3, N=300, Recruiting, Camurus AB | Not yet recruiting --> Recruiting

P2, N=40, Recruiting, Antonio Fojo | Not yet recruiting --> Recruiting | Trial primary completion date: May 2021 --> Dec 2021

P3, N=300, Not yet recruiting, Camurus AB