NEWS HIGHLIGHTS
Published Studies Related to Somatuline Depot (Lanreotide)
Lanreotide Reduces the Volume of Polycystic Liver: A Randomized, Double-Blind, Placebo-Controlled Trial. [2009.07.29]
BACKGROUND & AIMS: Therapy for polycystic liver is invasive, expensive, and has disappointing long-term results. Treatment with somatostatin analogues slowed kidney growth in patients with polycystic kidney disease (PKD) and reduced liver and kidney volume in a PKD rodent model. We evaluated the effects of lanreotide, a somatostatin analogue, in patients with polycystic liver because of autosomal-dominant (AD) PKD or autosomal-dominant polycystic liver disease (PCLD)... CONCLUSIONS: In patients with polycystic liver, 6 months of treatment with lanreotide reduces liver volume.
Effects of lanreotide SR and Autogel on tumor mass in patients with acromegaly: a systematic review. [2009.02.03]
Long-acting somatostatin analogs (SSA) are widely used for the treatment of acromegaly achieving biochemical control of the disease in 50-75% of the patients. One of the goals of the treatment of acromegaly is the control of tumor growth, especially in patients in whom SSAs are used as first-line therapy...
Lanreotide autogel every 6 weeks compared with Lanreotide microparticles every 3 weeks in patients with well differentiated neuroendocrine tumors: a Phase III Study. [2006.11.15]
BACKGROUND: The noninferiority of a 6-week dosing schedule of lanreotide Autogel (Lan ATG) at a dose of 120 mg compared with a 3-week dosing schedule of lanreotide microparticles (Lan MP) at a dose of 60 mg was investigated in patients with neuroendocrine tumors (NET)... CONCLUSIONS: Lan ATG at a dose of 120 mg every 6 weeks was as effective for controlling NET as Lan MP at a dose of 60 mg every 3 weeks.
Slow-release lanreotide in Graves' ophthalmopathy: A double-blind randomized, placebo-controlled clinical trial. [2006.05]
SS analogs are an attractive alternative in treating Graves' ophthalmopathy (GO). Most of the previous studies were uncontrolled and enrolled few patients... In conclusion, lanreotide treatment had no significant effects on GO compared with placebo.
Pharmacokinetic profile of lanreotide Autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 days. [2005.11]
OBJECTIVE: To investigate the pharmacokinetic profile of a prolonged release, aqueous Autogel formulation of the somatostatin analogue lanreotide (Lan-ATG)... CONCLUSIONS: Lan-ATG showed linear pharmacokinetic profiles over the three dose levels after both single and repeated dosing, no initial burst effect and good control over the entire release profile. Despite the absence of dose adaptation, four injections of Lan-ATG were effective in lowering serum levels of GH and IGF-1.
Clinical Trials Related to Somatuline Depot (Lanreotide)
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome [Recruiting]
The purpose of this study is to determine whether monthly injections of Somatuline Depot are
effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome.
Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study [Recruiting]
To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when
administered by a health care professional (HCP), the patient, the patient's partner or
parent/guardian as part of their routine acromegaly care.
Treatment of the Dumping Syndrome With Lanreotide Autogel® [Recruiting]
Background Somatostatin and octreotide LAR (long-acting analogue) exert a number of
inhibitory effects: on gut hormones, but also on gastro-intestinal secretion and motility.
Somatostatin analogues are effective in preventing symptoms and signs of both early and late
dumping as demonstrated previously. However, octreotide LAR causes gastrointestinal side
effects and the injection solution is difficult to prepare. Recently, a new somatostatin
analogue with a prolonged release formulation, Lanreotide autogel (L-autogel), has become
available. It is a viscous aqueous gel, composed solely of water and lanreotide. Deep
subcutaneous administration may lead to increased treatment acceptance compared with
intramuscular depot preparations. It is more easy to prepare and is though to cause less
local side effects and technical problems than octreotide LAR. Recent studies have been done
to measure the efficacy and safety of L-autogel in acromegalic treated previously with
octreotide LAR. These studies showed that L-autogel is effective and well-tolerated in these
patients, with equivalent or better disease control and less gastrointestinal adverse
events. Until now, there is no data available on the effectivety of L-autogel in patients
with a dumping syndrome. Therefore, this study aims to establish the effectiveness and
tolerability of L-autogel in patients with a dumping syndrome, previously treated with
octreotide LAR.
Lanreotide Levels in Acromegaly [Recruiting]
Recently lanreotide (a somatostatin analog) has come into the US marketplace as a
commercially available medication approved by the FDA for the treatment of acromegaly. Blood
levels in patients getting this drug are unknown and it may be critical to know the levels
in patients whose symptoms are poorly controlled.
This is a clinical study of a medical device where the following condition is met: This is
research on a medical device for which an investigational device exemption application (21
CFR Part 812) is not required.
The study is exempt from IDE requirements under 21 CFR 812. 2(c)(3):
The participants will be 10 CSMC patients who are taking Lanreotide for clinical purposes.
After receiving an information sheet and providing verbal consent, the participants will go
to their routine blood draw. At this time, they will have an additional 10 cc plasma drawn,
which will be sent to Intersciences Institute in Inglewood California to have the lanreotide
plasma levels measured.
The key points of this study are:
Patients will have blood drawn at the same time as they are having blood drawn for routine
care to avoid unnecessary sticks.
No patient identifiers will be sent to the lab or to any investigators- all plasma tubes
will be coded by ISI as a kit and these kits will be given to the physicians. In turn the
physician will give the kit to the patients who wish to have their levels measured and the
patient will take the kit with them to their routine blood draw. Following the drawing and
processing of the blood we will request that the lab just drop the coded plasma tube (and
the patient's height weight and monthly lanreotide dose) into the mail in the prepaid
mailer. The only information that the investigators will receive is the patient's height,
weight and monthly lanreotide dose and the plasma lanreotide level.
No more than 10 cc of blood (a couple of tablespoons) will be drawn for lanreotide
measurement.
Whenever possible plasma (which would otherwise be discarded) will be used rather than
freshly drawn blood.
All plasma will be assayed at ISI.
The patient will not be charged for the lanreotide assay, an investigational assay. The
assay is currently investigational and does not have a "maker" at this time.
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer [Recruiting]
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