Phase IIA study of Lanreotide PRF in subjects with Acromegaly
Research type
Research Study
Full title
Phase IIA, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects with Acromegaly Previously Treated and Controlled with Octreotide LAR
IRAS ID
165787
Contact name
Claude Bertrand
Contact email
Sponsor organisation
Ipsen Group
Eudract number
2014-002389-62
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
This is a clinical trial to determine the maximum dose, safety and tolerability of one injection of lanreotide prolonged release formulation (PRF) in patients with acromegaly previously treated with ocreotide long acting release (LAR).
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) from a pituitary tumour. Increased levels of GH in the body cause the symptoms and pathology of the disease, either directly through actions on target tissues, or indirectly by stimulating excessive secretion of insulin like growth factor-1 (IGF-1). This can result in severe disfigurement, complicating conditions, and premature death if unchecked.
It is a very rare disease (annual incidence: 3/1.000.000) and usually develops between the ages of 30 and 50.
Current medical treatments such as lanreotide act by reducing GF and IGF-1 secretion in approximately 70% of patients, which can alleviate many symptoms of acromegaly, improve related co morbid complications and may reduce or stabilise tumour size in a subset of patients.
At present Lanreotide is marketed for the long term treatment of Acromegaly as either Lanreotide prolonged release (PR); every 7, 10 or 14 days or Lanreotide Autogel; every 28 days. These treatments are effective with no safety concerns; however this frequent repeated treatment can be inconvenient for patients. The development of a more extended prolonged release formulation (PRF) of lanreotide will facilitate ease of use and treatment compliance for the patient.
A new formulation of lanreotide (Lanreotide PRF) has been developed with a view to increasing the dosing interval compared to the currently marked lanreotide formulations (lanreotide PR and lanreotide Autogel).
The development of lanreotide PRF, with a targeted dosing interval of 12 weeks, will therefore aid in reducing the burden of repeat administration for patients with acromegaly.REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0011
Date of REC Opinion
2 Mar 2015
REC opinion
Further Information Favourable Opinion