Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly

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Brief Title

Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly

Official Title

A Multicenter, Open, Prospective, Observational Study to Investigate the Effect of Lanreotide Autogel 120 mg on Control of GH and IGF-I Excess and Tumor Shrinkage in Newly Diagnosed Patients With Acromegaly

Brief Summary

      Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg
      was developed in order to further extend the duration of the release of the active
      ingredient. The ATG formulation consists of a solution of lanreotide in water with no
      additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg
      doses and provided a prolonged dosing interval and good tolerability (1). In some previous
      studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as
      octreotide-LAR in patients with acromegaly (4-7).

      Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking.
      Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This
      information is particularly useful in the setting of first-line therapy of acromegaly that is
      currently becoming a more frequent approach to the disease (8). It is demonstrated that
      approximately 80% of the patients treated with depot somatostatin analogues as first line
      have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A
      definition of significant tumor shrinkage was provided in 14 studies (including a total
      number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of
      patients receiving first-line somatostatin analogues therapy for acromegaly had a significant
      reduction in tumor size (10). About 50% of the patients were found to have a greater than 50%
      tumor shrinkage within the first year of treatment (10); in this study we found that percent
      decrease in IGF-I levels was the major determinant of tumor shrinkage (10).

      The current open, prospective study is designed to investigate the prevalence and amount of
      tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
    

Detailed Description

      This is an open, prospective, observational, clinical study to be performed in two University
      Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the efficacy of
      the ATG 120 mg on control of GH and IGF-I excess in acromegaly according with the currently
      accepted criteria (12) and on tumor shrinkage. The secondary objectives are to assess
      improvement of clinical symptoms and safety profile. The study population will consist of at
      least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th 2007. Patients
      give their written informed consent prior to entering into the study. The study was performed
      according to the principles defined by the declaration The safety population, as defined by
      the protocol, consists of patients who received at least one study drug dosing.

      Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals
      (starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of
      ATG. IGF-I levels are assessed as a single sample taken at each visit at the same time as the
      first GH sample. All hormonal parameters were assessed in a central laboratory (University of
      Genoa).

      Improvement in clinical symptoms is considered on the basis of a semiquantitative scale for
      asthenia, hyperhidrosis, headache, swelling of extremities, arthralgia, paraesthesia, carpal
      tunnel syndrome: symptoms were graded as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.

      Any adverse event (AE) during the study is monitored and reported by the investigators.
      Safety, evaluated by local laboratory data, is assessed at inclusion and at the final visit
      by: hematology: erythrocytes, leukocytes, platelets, haemoglobin, hematocrit; biochemistry:
      glucose, creatinine, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT),
      aspartate aminotransferase (AST), electrolytes (sodium, potassium, calcium, phosphorous)
      glycosylated haemoglobin, triglycerides, total and high density lipoproteins (HDL)
      cholesterol, blood amylase, iron, transferrin, prothrombin; glucose and insulin
      concentrations; hormonal evaluation: thyroid-stimulating hormone (TSH), free triiodothyronine
      (FT3), free triiodothyronine (FT4), follicle stimulating hormone (FSH) and luteinizing
      hormone (LH) levels. Safety related to gallbladder is assessed by ultrasound examination
      performed at inclusion and at the end of the study.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Control of GH and IGF-I excess and tumor shrinkage

Secondary Outcome

 Improvement of clinical symptoms and safety profile

Condition

Acromegaly

Intervention

Lanreotide-Autogel 120 mg

Study Arms / Comparison Groups

 A
Description:  Newly diagnosed patients with acromegaly

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

27

Start Date

January 2003

Completion Date

December 2007

Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with active acromegaly [serum GH levels above 2.5 μg/liter and/or above 1
             μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values] with a
             micro- (<10 mm max tumor diameter) or macroadenoma (>10 mm max tumor diameter)

          -  Patients never treated before

          -  Patients who do not require immediate surgery because of neurological symptoms and/or
             emergency conditions

          -  Patients who signed an informed consent to participate to the study.

        Exclusion Criteria:

          -  Patients already treated before with surgery or radiotherapy or with medical treatment

          -  Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine
             treatment
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Annamaria Colao, MD, PhD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00627796

Organization ID

NeuroendoUnit-9



Study Sponsor

Federico II University

Collaborators

 University of Genova

Study Sponsor

Annamaria Colao, MD, PhD, Principal Investigator, Federico II University


Verification Date

December 2007