Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

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Brief Title

Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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)

Secondary Outcome

 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).

Condition

Acromegaly

Intervention

Lanreotide autogel 120 mg

Study Arms / Comparison Groups

 Lanreotide autogel 120 mg
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

108

Start Date

May 2008

Completion Date

February 2012

Primary Completion Date

February 2012

Eligibility 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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00690898

Organization ID

2-79-52030-207

Secondary IDs

2007-000155-34

Responsible Party

Sponsor

Study Sponsor

Ipsen


Study Sponsor

Ipsen Medical Director, Study Director, Ipsen


Verification Date

January 2019