ACROMEGALY ASSOCIATED WITH PITUITARY GLAND MACROADENOMA MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Product Name: lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LANREOTIDE
CAS Number: 108736352
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Beaufour Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -The patient has given written informed consent prior to any study related procedures, -The patient is male or female and is aged between 18 and 75 years, inclusive, -Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients (GH profile - central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results), -The patient has a pituitary adenoma with a diameter > or = 10 mm based on Magnetic Resonance Imaging (MRI) central reading, -The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter. 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 a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure, -The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study, -The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine, -The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive method. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide) or injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study, -The patient is pregnant or lactating, -The patient has a history of, or known current, problems with alcohol abuse, -The patient has any mental condition rendering the patient 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 patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study, -The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry, -The patient has previously been treated with a somatostatin analogue, -The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry, -The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period, -Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central laboratory), -Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), -Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality potentially influencing the visual field interpretation (e.g. glaucoma, congenital optic disc anomalies, drusen, retinis pigmentosa….). Under no circumstances will patients be enrolled more than once.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Lanreotide Autogel 120 mg when used as primary medical treatment in untreated de novo acromegalic patients with macroadenoma, as assessed by evaluating the change in pituitary tumor volume at Week 48 (after 12 injection – V5) compared to baseline (V2). A 20% reduction from the baseline volume will be considered to be clinically significant. ;Secondary Objective: (1) To assess the change in tumor volume after 3 injections (V3) and 6 injections (V4) compared to baseline, (2) To assess the change in GH, IGF-1 and prolactin* levels at all assessment time-points in comparison to the baseline visit, (3) To assess the therapeutic activity of Lanreotide Autogel 120 mg as primary medical treatment on: - Acromegaly symptoms, - Quality of life (using AcroQOL)** (4) To assess safety based on: - Adverse events, clinical examination, vital signs, - Glucose tolerance, - Standard haematology and biochemistry, - Gallbladder ultrasound. *prolactin will only be assessed in patients who presented an initial increased prolactin level at V1 (20ng/mL < prolactin < or = 100 ng/mL). **AcroQOL will only be assessed in countries where a validated translation is available. ;Primary end point(s): The primary efficacy endpoint will be the percentage of patients with significant reduction in tumor volume from baseline (Visit V2) to W48 (Visit V5). A reduction by 20% of the original volume will be considered to be clinically significant. | — |
Countries
Belgium, Czech Republic, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed