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

NCT00627796 | Completed Phase 4

• 1 other identifier: NeuroendoUnit-9
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Keywords

GH; IGF-I; tumor; lanreotide

Outcome Measures

Primary Outcomes (1)

• Control of GH and IGF-I excess and tumor shrinkage

  3 and 12 months

Secondary Outcomes (1)

• Improvement of clinical symptoms and safety profile

  3 and 12 months

Study Arms (1)

A

EXPERIMENTAL

Newly diagnosed patients with acromegaly

Drug: Lanreotide-Autogel 120 mg

Interventions

Lanreotide-Autogel 120 mg DRUG

ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were \> 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were \< 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels \<1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration.

Also known as: Ipstyl

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead
• University of Genova: collaborator

Study Sites (1)

Annamaria Colao

Naples, 80131, Italy

Location

Related Publications (11)

• Antonijoan RM, Barbanoj MJ, Cordero JA, Peraire C, Obach R, Valles J, Cherif-Cheikh R, Torres ML, Bismuth F, Montes M. Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteers. J Pharm Pharmacol. 2004 Apr;56(4):471-6. doi: 10.1211/0022357023123.

  PMID: 15099442 RESULT

• Caron P, Beckers A, Cullen DR, Goth MI, Gutt B, Laurberg P, Pico AM, Valimaki M, Zgliczynski W. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly. J Clin Endocrinol Metab. 2002 Jan;87(1):99-104. doi: 10.1210/jcem.87.1.8153.

  PMID: 11788630 RESULT

• Lucas T, Astorga R; Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly. Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial. Clin Endocrinol (Oxf). 2006 Sep;65(3):320-6. doi: 10.1111/j.1365-2265.2006.02595.x.

  PMID: 16918950 RESULT

• Ashwell SG, Bevan JS, Edwards OM, Harris MM, Holmes C, Middleton MA, James RA. The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR. Eur J Endocrinol. 2004 Apr;150(4):473-80. doi: 10.1530/eje.0.1500473.

  PMID: 15080776 RESULT

• Alexopoulou O, Abrams P, Verhelst J, Poppe K, Velkeniers B, Abs R, Maiter D. Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR. Eur J Endocrinol. 2004 Sep;151(3):317-24. doi: 10.1530/eje.0.1510317.

  PMID: 15362960 RESULT

• van Thiel SW, Romijn JA, Biermasz NR, Ballieux BE, Frolich M, Smit JW, Corssmit EP, Roelfsema F, Pereira AM. Octreotide long-acting repeatable and lanreotide Autogel are equally effective in controlling growth hormone secretion in acromegalic patients. Eur J Endocrinol. 2004 Apr;150(4):489-95. doi: 10.1530/eje.0.1500489.

  PMID: 15080778 RESULT

• Ronchi CL, Boschetti M, Degli Uberti EC, Mariotti S, Grottoli S, Loli P, Lombardi G, Tamburrano G, Arvigo M, Angeletti G, Boscani PF, Beck-Peccoz P, Arosio M; Italian Multicenter Autogel Study Group in Acromegaly. Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study. Clin Endocrinol (Oxf). 2007 Oct;67(4):512-9. doi: 10.1111/j.1365-2265.2007.02917.x. Epub 2007 Jun 7.

  PMID: 17555511 RESULT

• Colao A, Martino E, Cappabianca P, Cozzi R, Scanarini M, Ghigo E; A.L.I.C.E. Study Group. First-line therapy of acromegaly: a statement of the A.L.I.C.E. (Acromegaly primary medical treatment Learning and Improvement with Continuous Medical Education) Study Group. J Endocrinol Invest. 2006 Dec;29(11):1017-20. doi: 10.1007/BF03349217. No abstract available.

  PMID: 17259801 RESULT

• Bevan JS. Clinical review: The antitumoral effects of somatostatin analog therapy in acromegaly. J Clin Endocrinol Metab. 2005 Mar;90(3):1856-63. doi: 10.1210/jc.2004-1093. Epub 2004 Dec 21.

  PMID: 15613435 RESULT

• Melmed S, Sternberg R, Cook D, Klibanski A, Chanson P, Bonert V, Vance ML, Rhew D, Kleinberg D, Barkan A. A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4405-10. doi: 10.1210/jc.2004-2466. Epub 2005 Apr 12.

  PMID: 15827109 RESULT

• Colao A, Auriemma RS, Rebora A, Galdiero M, Resmini E, Minuto F, Lombardi G, Pivonello R, Ferone D. Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly. Clin Endocrinol (Oxf). 2009 Aug;71(2):237-45. doi: 10.1111/j.1365-2265.2008.03503.x. Epub 2008 Dec 15.

  PMID: 19094074 DERIVED

MeSH Terms

Conditions

Acromegaly; Neoplasms

Interventions

lanreotide

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

Study Officials

• Annamaria Colao, MD, PhD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: January 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 3, 2008

Record last verified: 2007-12

Locations

IT (1)