Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

NCT ID: NCT00383708

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-10-31

Brief Summary

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

lanreotide (Autogel formulation)

Intervention Type: DRUG

120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.

Pegvisomant

Intervention Type: DRUG

Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Interventions

lanreotide (Autogel formulation)

120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.

Intervention Type: DRUG

Pegvisomant

Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels
• The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the last injection
• At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg

Exclusion Criteria

• The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry, or it is anticipated that it will be done during the study
• The patient has already been treated with a somatostatin analogue associated with a GH antagonist
• The patient has received dopamine agonist within 6 weeks prior to the study entry
• The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)
• The patient is at risk of pregnancy or is lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

University Hospital, Charles University

Hradec Králové, , Czechia

Charles University

Prague, , Czechia

Aarhus Kommunehospital

Aarhus, , Denmark

Groupe Hospitalier Henri Mondor- Albert Chenevier

Créteil, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Clinique Marc Linquette

Lille, , France

Hôpital de la Timone

Marseille, , France

CHU de Rangueil

Toulouse, , France

Charite Campus Mitte

Berlin, , Germany

Klinikum Johann Wolfgang Goethe-Universität

Frankfurt, , Germany

Medizinische Klinik Innenstadt

München, , Germany

Anticancer Hospital Metaxa Piraeus

Piraeus, , Greece

Universitá degli Studi di Milano

Milan, , Italy

University Federico II

Napoli, , Italy

Universitá di Torino

Torino, , Italy

Leiden University Medical Center

Leiden, , Netherlands

Dept. of Internal Medicine Erasmus MC

Rotterdam, , Netherlands

Hospital General de Alicante

Alicante, , Spain

Clínica Puerta de Hierro

Madrid, , Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Sahlgrenska University Hospital

Gothenburg, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Christie Hospital and Holt Radium Institute

Manchester, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Czechia; Denmark; France; Germany; Greece; Italy; Netherlands; Spain; Sweden; United Kingdom

References

van der Lely AJ, Bernabeu I, Cap J, Caron P, Colao A, Marek J, Neggers S, Birman P. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011 Mar;164(3):325-33. doi: 10.1530/EJE-10-0867. Epub 2010 Dec 10.

Reference Type: RESULT

PMID: 21148630 (View on PubMed)

Other Identifiers

2-55-52030-727

Identifier Type: -

Identifier Source: org_study_id