Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

NCT00690898 | Completed Phase 3 Results DMC

• 2 other identifiers: 2-79-52030-2072007-000155-34
• Study Type: interventional
• Target: 108
• Locations: 9 countries
• Sites: 27

Brief Summary

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Week 1 and Week 48

Secondary Outcomes (10)

• 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).

  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

  Week 12, 24, and 48

• Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.

  Week 12, 24, and 48

• Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels

  Week 12, 24 and 48

• Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline

  Week 12, 24 and 48

Study Arms (1)

Lanreotide autogel 120 mg

EXPERIMENTAL

Drug: Lanreotide autogel 120 mg

Interventions

Lanreotide autogel 120 mg DRUG

12 months

Lanreotide autogel 120 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (27)

University Hospital Antwerpen

Edegem, B2650, Belgium

Location

Všeobecná fakultní nemocnice, Karlova Univerzita

Prague, 128 08 Praha 2, Czechia

Location

Helsinki University Center Hospital

Helsinki, 9 FIN-00290, Finland

Location

The Turku University Central Hospital

Turku, 20520, Finland

Location

Hopital De Bois Guillaume

Bois-Guillaume, 76230 Cedex, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble Albert Michallon

Grenoble, 38043 Cedex, France

Location

CHRU Lille Hopital Claude Huriez

Lille, France

Location

Groupement Hospitalier Est

Lyon, 69677 Bron Cedex, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital Bicêtre

Paris, 94275 Cedex, France

Location

Hopital Haut Leveque

Pessac, 33604 Cedex, France

Location

CHU de Reims, Hopital Robert Debré

Reims, France

Location

Friedrich-Alexander University

Erlangen, 91054, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, 60590, Germany

Location

ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie

Hamburg, 20357, Germany

Location

Medizinische Klinik Innenstadt

München, 80336, Germany

Location

AOU Policlinico "G. Martino" Messina

Messina, 98125, Italy

Location

Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia

Napoli, 5 80131, Italy

Location

Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia

Roma, 00168, Italy

Location

ERASMUS MC Rotterdam

Rotterdam, 3000, Netherlands

Location

UMC Utrecht

Utrecht, 3508, Netherlands

Location

Cerrahpasa Medical Facility

Istanbul, 34303, Turkey (Türkiye)

Location

27/28 Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (2)

• 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: 24423301 RESULT

• 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.

  PMID: 26603536 DERIVED

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Endocrinology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 14, 2022
• Results First Posted: December 23, 2013

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

IT (3); FR (9); DE (5); TU (1); NL (2); BE (1); CZ (1); FI (2); GB (3)