Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma (PRIMARYS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00690898
First received: June 3, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: Lanreotide autogel 120 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels [ Time Frame: Week 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline [ Time Frame: Week 12, 24 and 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.


Enrollment: 108
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanreotide autogel 120 mg Drug: Lanreotide autogel 120 mg
12 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ( 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690898

Locations
Belgium
University Hospital Antwerpen
Edegem, Belgium, B2650
Czech Republic
Všeobecná fakultní nemocnice, Karlova Univerzita
Praha, Czech Republic, 128 08 Praha 2
Finland
Helsinki University Center Hospital
Helsinki, Finland, 9 FIN-00290
The Turku University Central Hospital
Turku, Finland, 20520
France
Hopital De Bois Guillaume
Bois-Guillaume, France, 76230 Cedex
CHU Henri Mondor
Créteil, France, 94010
CHU Grenoble Albert Michallon
Grenoble, France, 38043 Cedex
CHRU Lille Hopital Claude Huriez
Lille, France
Groupement Hospitalier Est
Lyon, France, 69677 Bron Cedex
Hôpital de la Timone
Marseille, France, 13385
Hôpital Bicêtre
Paris, France, 94275 Cedex
Hopital Haut Leveque
Pessac, France, 33604 Cedex
CHU de Reims, Hopital Robert Debré
Reims, France
Germany
Friedrich-Alexander University
Erlangen, Germany, 91054
Universitatsklinikum Essen
Essen, Germany, 45122
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 60590
ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie
Hamburg, Germany, 20357
Medizinische Klinik Innenstadt
München, Germany, 80336
Italy
AOU Policlinico "G. Martino" Messina
Messina, Italy, 98125
Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia
Napoli, Italy, 5 80131
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia
Roma, Italy, 00168
Netherlands
ERASMUS MC Rotterdam
Rotterdam, Netherlands, 3000
UMC Utrecht
Utrecht, Netherlands, 3508
Turkey
Cerrahpasa Medical Facility
Istanbul, Turkey, 34303
United Kingdom
27/28 Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Christie Hospital
Manchester, United Kingdom, M20 4BX
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Antoine Clermont, MD Ipsen
  More Information

Publications:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00690898     History of Changes
Other Study ID Numbers: 2-79-52030-207, 2007-000155-34
Study First Received: June 3, 2008
Results First Received: November 4, 2013
Last Updated: February 27, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ministry of Health
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Finland: Finnish Medicines Agency
Turkey: Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014