^
10d
SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET (clinicaltrials.gov)
P3, N=332, Active, not recruiting, Camurus AB | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Oclaiz (octreotide subcutaneous depot) • octreotide acetate
12d
Pachydermoperiostosis Due to a Novel HPGD Splicing Site Mutation Masquerading as Acromegaly. (PubMed, JCEM Case Rep)
Reverse transcription polymerase chain reaction confirmed that this variant led to defective splicing with skipping of exon 6, a frameshift, and truncation at codon 13 of exon 7 downstream. His symptoms did not respond well to nonsteroidal anti-inflammatory drugs but showed excellent response to a trial of lanreotide autogel that has been used for about 1 year.
Journal
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
21d
Enrollment change
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
5ms
Medical treatment of acromegaly - When the tumor size matters: A narrative review. (PubMed, Growth Horm IGF Res)
Therefore, an individual approach is necessary in the treatment of patients with acromegaly, based on repeated insight to their clinical, biochemical, pathological and imaging characteristics. In this review, we summarize and comment how pituitary tumor size is affected by the treatment with all currently available drugs in acromegaly: long-acting somatostatin receptor ligands of the first generation (octreotide LAR and lanreotide autogel) and the second generation (pasireotide-LAR), as well as pegvisomant (PEG) and cabergoline (CAB).
Review • Journal
|
SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Signifor LAR (pasireotide long acting release) • octreotide acetate
5ms
Lanreotide versus placebo for tumour reduction in patients with a 68Ga-DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma (GALANT study): a randomised, multicentre, phase 3 trial with blinded outcome assessment. (PubMed, Lancet Reg Health Eur)
A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks...Compared with placebo, lanreotide treatment did not reduce tumour size or growth in patients with 68Ga-DOTATATE PET-positive NFPMA. Ipsen Farmaceutica BV.
P3 data • Journal
|
SSTR (Somatostatin Receptor)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
6ms
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors (clinicaltrials.gov)
P1/2, N=49, Recruiting, National Health Research Institutes, Taiwan | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Metastases
|
Cabometyx (cabozantinib tablet) • Somatuline Depot (lanreotide prolonged-release subcutaneous)
6ms
Treatment of Advanced BP-NETS with Lanreotide Autogel/Depot vs Placebo: the Phase III SPINET Study. (PubMed, Endocr Relat Cancer)
Patients' quality of life did not deteriorate and LAN was well tolerated. Although recruitment stopped early and the predefined sample size was not met, SPINET is the largest prospective study to date of SSA therapy in SSTR positive TCs and ACs and suggests clinical benefit in TCs.
P3 data • Journal • Metastases
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SSTR (Somatostatin Receptor)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
8ms
Enrollment closed • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
8ms
Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy (clinicaltrials.gov)
P4, N=3, Completed, Sheba Medical Center | Unknown status --> Completed | N=10 --> 3
Trial completion • Enrollment change
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
9ms
Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China (clinicaltrials.gov)
P=N/A, N=129, Active, not recruiting, Ipsen | Recruiting --> Active, not recruiting | N=210 --> 129
Enrollment closed • Enrollment change • Real-world evidence • Real-world
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
11ms
SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (clinicaltrials.gov)
P3, N=332, Active, not recruiting, Camurus AB | Recruiting --> Active, not recruiting
Enrollment closed
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Oclaiz (octreotide subcutaneous depot) • octreotide acetate
11ms
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. (PubMed, Trials)
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.
P3 data • Clinical Trial,Phase III • Journal
|
SSTR (Somatostatin Receptor)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Oclaiz (octreotide subcutaneous depot) • octreotide acetate
12ms
Combined Lanreotide Autogel and Temozolomide Treatment of Progressive Pancreatic and Intestinal Neuroendocrine Tumors: The Phase II SONNET Study. (PubMed, Oncologist)
LAN plus TMZ is a treatment option for patients with progressive GEP-NET with more aggressive biological profile showing a manageable safety profile.
P2 data • Journal
|
CHGA (Chromogranin A)
|
temozolomide • Somatuline Depot (lanreotide prolonged-release subcutaneous)
1year
Trial completion date • Trial primary completion date • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
1year
OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov)
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
Enrollment closed • Phase classification • Trial completion date • Trial primary completion date
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IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
1year
Phase classification • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
1year
Assessing the safety and activity of cabozantinib combined with lanreotide in gastroenteropancreatic and thoracic neuroendocrine tumors: rationale and protocol of the phase II LOLA trial. (PubMed, BMC Cancer)
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.
P2 data • Journal
|
MET (MET proto-oncogene, receptor tyrosine kinase) • AXL (AXL Receptor Tyrosine Kinase) • KDR (Kinase insert domain receptor) • SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
|
KDR expression
|
Cabometyx (cabozantinib tablet) • Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
OPERA: perception of information in patients with GEP-NETs on lanreotide autogel. (PubMed, Eur J Endocrinol)
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.
Journal
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
Enrollment change • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
over1year
An international simulated-use study to assess nurses' preferences between two lanreotide syringes for patients with neuroendocrine tumours or acromegaly (PRESTO 3). (PubMed, J Endocrinol Invest)
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.
Journal
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
AIM-NETs: Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs (clinicaltrials.gov)
P=N/A, N=95, Recruiting, Asan Medical Center | Trial primary completion date: Jan 2023 --> Jan 2024
Trial primary completion date • Metastases
|
CHGA (Chromogranin A)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
Real world use of lanreotide in neuroendocrine tumors. (PubMed, J Gastrointest Oncol)
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.
Journal • Real-world evidence • Real-world
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Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
Satisfaction with injection experience of patients with neuroendocrine tumors enrolled on lanreotide autogel patient support programs: Results from the international HomeLAN survey. (PubMed, J Neuroendocrinol)
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.
Journal
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
over1year
OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov)
P1b, N=30, Recruiting, Debiopharm International SA | Trial completion date: Feb 2025 --> Jun 2025 | Trial primary completion date: Jan 2025 --> May 2025
Trial completion date • Trial primary completion date
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
over1year
Randomized, Placebo-Controlled Phase 3 Trial Protocol Assessing the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients with Acromegaly (ENDO 2023)
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.*
Clinical • P3 data
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Signifor (pasireotide) • Oclaiz (octreotide subcutaneous depot) • Octreosphere (octreotide extended release) • octreotide acetate
over1year
Novel Approach To Management of Acromegaly with De Novo Oral Octreotide Or Combination Therapy with Cabergoline: A Case Series (ENDO 2023)
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.*
Clinical • Combination therapy
|
SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
|
IGF1 elevation
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Signifor (pasireotide) • octreotide acetate
over1year
Treatment Patterns in Acromegaly: Analysis of Real-World US Insurance Claims from the MarketScan® Database (ENDO 2023)
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.*
Clinical • Reimbursement • US reimbursement • Real-world evidence • Real-world
|
SSTR (Somatostatin Receptor)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Signifor (pasireotide) • octreotide acetate
over1year
Enrollment open • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
over1year
Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors (clinicaltrials.gov)
P1/2, N=49, Recruiting, National Health Research Institutes, Taiwan | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Cabometyx (cabozantinib tablet) • Somatuline Depot (lanreotide prolonged-release subcutaneous)
almost2years
Enrollment closed • Metastases
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
almost2years
Mask off: a deceptive case of pancreatic mass (BWG 2023)
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.
Clinical
|
AFP (Alpha-fetoprotein) • SSTR (Somatostatin Receptor) • CA 19-9 (Cancer antigen 19-9)
|
AFP elevation
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
almost2years
PALACE: Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs (clinicaltrials.gov)
P3, N=43, Completed, Ipsen | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Jan 2023
Trial completion • Trial completion date • Metastases
|
CHGA (Chromogranin A)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous)
2years
A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly. (PubMed, Pituitary)
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.
Review • Journal
|
SSTR (Somatostatin Receptor) • IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Signifor LAR (pasireotide long acting release) • octreotide acetate
over2years
Efficacy and Safety of Lanreotide Autogel and Temozolomide Combination Therapy in Progressive Thoracic Neuroendocrine Tumors (carcinoid): Results from the Phase 2 ATLANT Study. (PubMed, Neuroendocrinology)
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.
P2 data • Journal • Combination therapy
|
SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2) • CHGA (Chromogranin A)
|
temozolomide • Somatuline Depot (lanreotide prolonged-release subcutaneous)
over2years
OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov)
P1b, N=30, Recruiting, Debiopharm International SA | Trial completion date: Jul 2024 --> Feb 2025 | Trial primary completion date: Jun 2024 --> Jan 2025
Trial completion date • Trial primary completion date
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
over2years
New P1 trial
|
SSTR (Somatostatin Receptor)
|
sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate
over2years
Enrollment open
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
over2years
Trial completion date
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
over2years
New P1 trial
|
IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide 3-month extended release (Debio 4126) • octreotide acetate
almost3years
A prospective study on the efficacy of oral estrogen in female patients with acromegaly. (PubMed, Pituitary)
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.
Journal
|
ER (Estrogen receptor) • IGF1 (Insulin-like growth factor 1)
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • Octreosphere (octreotide extended release) • octreotide acetate
almost3years
Self-Administration of Long-Acting Somatostatin Analogues in NET Patients-Does It Affect the Clinical Outcome? (PubMed, Medicina (Kaunas))
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.
Clinical • Clinical data • Journal
|
SSTR (Somatostatin Receptor)
|
SSTR Expression
|
Somatuline Depot (lanreotide prolonged-release subcutaneous) • octreotide acetate