Acromegaly MedDRA version: 8.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Trade Name: Somatuline Autogel 120 MG
Product Name: lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lanreotide
CAS Number: 108736-35-2
Concentration unit: mg
Sponsors
BEAUFOUR IPSEN Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the screening visit: • Provision of written informed consent prior to any study related procedures. • Male or female aged between 18 and 75 years inclusive. • The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels. • The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 levels, or IGF-1 level above ULN after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including the last 3 months at the highest marketed dose, and has a serum IGF-1 level above ULN, 28 days after the last injection. At the end of the run-in period: • The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and a 1.2 x ULN and a serum GH nadir > 1 µg/L ( assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg. • The patient is diabetic and has a serum IGF-1 level above 1.2 x ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The patient has undergone pituitary surgery or raditherapy within 6 months prior to study entry. • It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. • The patient has a history of hypersensitivity to lanreotide or pegvisomant or drugs with a similar chemical structure. • The patient has already been treated with a somatostatin analogue associated with a GH antagonist. • The patient has received a dopamine agonist within 6 weeks prior to study entry. • The patient has been treated with any unlicensed drug within the last 30 days before study entry. • The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol. • The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN). • The patient is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study. • The patient has a history of, or known current, problems with alcohol or drug abuse. • The patient has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. • The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period. ;Secondary Objective: To assess the effect of lanreotide - pegvisomant co-administration on: • Acromegaly symptoms. • Quality of life. • Safety based on: - Adverse events, clinical examination, vital signs - Glucose tolerance - Standard haematology and biochemistry - Gallbladder ultrasound - Pituitary tumour size - ECG - Putative anti-lanreotide Autogel antibodies, anti-pegvisomant antibodies. Lanreotide and pegvisomant serum levels (minimum observed concentrations Cmin). Additional Objectives: To assess the effect of lanreotide - pegvisomant co-administration on: • GH, GH binding protein, acid labile subunit, and prolactin levels.;Primary end point(s): The primary efficacy endpoint will be the percentage of patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period. | — |
Countries
Czech Republic, Germany, Greece, Italy, Sweden, United Kingdom
Outcome results
None listed