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

NCT00627796 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2008-03-03

No results posted yet for this study

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

Interventions

DRUG

Lanreotide-Autogel 120 mg

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.

Sponsors & Collaborators

  • University of Genova

    collaborator OTHER

  • Federico II University

    lead OTHER

Principal Investigators

  • Annamaria Colao, MD, PhD · Federico II University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627796 on ClinicalTrials.gov