DRUG
Lanreotide autogel 120 mg
12 months
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Status
Completed
Phase
Phase 3
Enrollment
108
Locations
27
Results
Posted
Publications
2
Study summary
What the protocol is testing.
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland. The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life. Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 5, 2008
Study start
May 2008
Primary completion
Feb 2012
Study completion
Feb 2012
Results posted
Dec 23, 2013
Registry updated
Oct 14, 2022
Outcomes
What the study measures.
Primary outcomes
Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)
Time frame · Week 1 and Week 48
A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.
Secondary outcomes
Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).
Time frame · Baseline (week 1) to week 12 and week 24
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels
Time frame · Week 12, 24, and 48
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.
Time frame · Week 12, 24, and 48
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Time frame · Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Time frame · Week 12, 24 and 48
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Time frame · Week 12, 24 and 48
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Time frame · Week 12, 24 and 48
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Time frame · Week 12, 24 and 48
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Time frame · Week 12, 24 and 48
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Time frame · Week 12, 24 and 48
Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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 ( 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 greater than or equal to 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, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement: * Not related to the pituitary adenoma * Clinically stable condition not presumed to change during the study period * Not modifying the ability to evaluate visual field changes related to the macroadenoma 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 or drugs that are not permitted by the study protocol, * The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. 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), 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 jeopardize 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 results), * 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 with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.
Study locations
27 registered sites.
Belgium · Czechia · Finland · France · Germany · Italy · Netherlands · Turkey (Türkiye) · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
University Hospital Antwerpen
Edegem, Belgium
Všeobecná fakultní nemocnice, Karlova Univerzita
Prague, Czechia
Helsinki University Center Hospital
Helsinki, Finland
The Turku University Central Hospital
Turku, Finland
Hopital De Bois Guillaume
Bois-Guillaume, France
CHU Henri Mondor
Créteil, France
CHU Grenoble Albert Michallon
Grenoble, France
CHRU Lille Hopital Claude Huriez
Lille, France
Groupement Hospitalier Est
Lyon, France
Hôpital de la Timone
Marseille, France
Hôpital Bicêtre
Paris, France
Hopital Haut Leveque
Pessac, France
CHU de Reims, Hopital Robert Debré
Reims, France
Friedrich-Alexander University
Erlangen, Germany
Universitatsklinikum Essen
Essen, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, Germany
ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie
Hamburg, Germany
Medizinische Klinik Innenstadt
München, Germany
AOU Policlinico "G. Martino" Messina
Messina, Italy
Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia
Naples, Italy
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia
Roma, Italy
ERASMUS MC Rotterdam
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Cerrahpasa Medical Facility
Istanbul, Turkey (Türkiye)
Publications
Results and literature.
PMID 24423301 ↗Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prevost G, Maisonobe P, Clermont A; PRIMARYS Investigators. Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial. J Clin Endocrinol Metab. 2014 Apr;99(4):1282-90. doi: 10.1210/jc.2013-3318. Epub 2013 Jan 1.PMID 26603536 ↗Caron PJ, Bevan JS, Petersenn S, Houchard A, Sert C, Webb SM; PRIMARYS Investigators Group. Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study. Pituitary. 2016 Apr;19(2):149-57. doi: 10.1007/s11102-015-0693-y.
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