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Trial · Interventional

CompletedPhase 4Registry data

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

Short name ATG1line

NCTNCT00627796 (opens ClinicalTrials.gov in a new tab)Other idNeuroendoUnit-9
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
27 participants (actual)
Sponsor
Federico II University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Italy

Start
Jan 2003
Primary completion
Dec 2007
Completion
Dec 2007
First posted
3 Mar 2008 (estimated)
Last update posted
3 Mar 2008 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005200620072008
  1. Ph 4

    ATG1line

    NCT00627796

    Jan 2003 to Dec 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lanreotide-Autogel 120 mgDrug

Arms1

  • Experimental

    A

    Newly diagnosed patients with acromegaly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Control of GH and IGF-I excess and tumor shrinkage

    Time frame · 3 and 12 months

Secondary outcomes(1)

  1. Improvement of clinical symptoms and safety profile

    Time frame · 3 and 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies9

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2007

15 results

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.

Ronchi et al. 2007Clinical endocrinologycited by 52

PMID 17555511DOI 10.1111/j.1365-2265.2007.02917.xPUB-17555511

Full text at the publisher15 results
Publisher pageSee results (15)

Indexing hint: Clinical trial · 2006

5 results

Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial.

Lucas et al. 2006Clinical endocrinologycited by 40

PMID 16918950PMC1618957DOI 10.1111/j.1365-2265.2006.02595.xPUB-16918950

CC BY5 results
Download PDFSee results (5)

More studies

7 studies on this page

Indexing hint: Clinical trial · 2009

Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly.

Colao et al. 2009Clinical endocrinologycited by 45

PMID 19094074DOI 10.1111/j.1365-2265.2008.03503.xPUB-19094074

Full text at the publisher
Publisher page

PubMed tag: none · 2005

A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly.

Melmed et al. 2005The Journal of clinical endocrinology and metabolismcited by 134

PMID 15827109DOI 10.1210/jc.2004-2466PUB-15827109

Rights unknown
Source link

Indexing hint: Clinical trial · 2004

The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR.

Ashwell et al. 2004European journal of endocrinologycited by 37

PMID 15080776DOI 10.1530/eje.0.1500473PUB-15080776

Rights unknown
Source link

Indexing hint: Clinical trial · 2004

Octreotide long-acting repeatable and lanreotide Autogel are equally effective in controlling growth hormone secretion in acromegalic patients.

van Thiel et al. 2004European journal of endocrinologycited by 50

PMID 15080778DOI 10.1530/eje.0.1500489PUB-15080778

Rights unknown
Source link

Indexing hint: Clinical trial · 2004

Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteers.

Antonijoan et al. 2004The Journal of pharmacy and pharmacologycited by 38

PMID 15099442DOI 10.1211/0022357023123PUB-15099442

Rights unknown
Source link

Indexing hint: Clinical trial · 2004

Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR.

Alexopoulou et al. 2004European journal of endocrinologycited by 60

PMID 15362960DOI 10.1530/eje.0.1510317PUB-15362960

Rights unknown
Source link

Indexing hint: Clinical trial · 2002

Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly.

Caron et al. 2002The Journal of clinical endocrinology and metabolismcited by 126

PMID 11788630DOI 10.1210/jcem.87.1.8153PUB-11788630

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultColao 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
  • ResultBevan 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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