Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00383708
First received: October 2, 2006
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: lanreotide (Autogel formulation)
Drug: Pegvisomant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • The percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period. [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acromegaly symptoms [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Adverse events, clinical evaluation, vital signs [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Glucose tolerance [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Standard haematology and biochemistry [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Gallbladder ultrasound [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Pituitary tumor size [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • ECG [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Anti-lanreotide Autogel antibodies, anti-pegvisomant antibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Lanreotide and pegvisomant serum levels (minimum observed concentrations Cmin) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • To assess the effect of lanreotide - pegvisomant co-administration on: GH, GH binding protein, acid labile subunit and prolactin levels [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: October 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: lanreotide (Autogel formulation)
120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
Drug: Pegvisomant
Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383708

Locations
Czech Republic
University Hospital, Charles University
Hradec Kralove, Czech Republic, 500 05
Charles University
Prague, Czech Republic, 120 00 PRAHA 2
Denmark
Aarhus Kommunehospital
Aarhus, Denmark
France
Groupe Hospitalier Henri Mondor- Albert Chenevier
Créteil Cedex, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Clinique Marc Linquette
Lille Cedex, France, 59037
Hôpital de la Timone
Marseille Cedex, France, 13385
CHU de Rangueil
Toulouse, France, 31054
Germany
Charite Campus Mitte
Berlin, Germany, 10117
Klinikum Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 605090
Medizinische Klinik Innenstadt
Munchen, Germany, 80336
Greece
Anticancer Hospital Metaxa Piraeus
Piraeus, Greece, 18537
Italy
Universitá degli Studi di Milano
Milano, Italy, 20122
University Federico II
Napoli, Italy, 80131
Universitá di Torino
Torino, Italy, 10126
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Dept. of Internal Medicine Erasmus MC
Rotterdam, Netherlands, 3015 GD
Spain
Hospital General de Alicante
Alicante, Spain, 03012
Clínica Puerta de Hierro
Madrid, Spain, 28035
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 413 45
Uppsala University Hospital
Uppsala, Sweden, 75185
United Kingdom
Christie Hospital and Holt Radium Institute
Manchester, United Kingdom, M20 4BX
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Pascal Birman, MD Ipsen
  More Information

Publications:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00383708     History of Changes
Other Study ID Numbers: 2-55-52030-727
Study First Received: October 2, 2006
Last Updated: June 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Greece: National Organization of Medicines
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014