Full Text View
Tabular View
No Study Results Posted
Related Studies
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
This study has been completed.
First Received: October 2, 2006   Last Updated: August 27, 2009   History of Changes
Sponsor: Ipsen
Information provided by: Ipsen
ClinicalTrials.gov Identifier: NCT00383708
  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 III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
1: Experimental 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383708

Locations
Czech Republic
Charles University
Prague, Czech Republic, 120 00 PRAHA 2
University Hospital, Charles University
Hradec Kralove, Czech Republic, 500 05
Denmark
Aarhus Kommunehospital
Aarhus, Denmark
France
Clinique Marc Linquette
Lille Cedex, France, 59037
CHU de Rangueil
Toulouse, France, 31054
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Hôpital de la Timone
Marseille Cedex, France, 13385
Groupe Hospitalier Henri Mondor- Albert Chenevier
Créteil Cedex, France
Germany
Charite Campus Mitte
Berlin, Germany, 10117
Medizinische Klinik Innenstadt
Munchen, Germany, 80336
Klinikum Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 605090
Greece
Anticancer Hospital Metaxa Piraeus
Piraeus, Greece, 18537
Italy
Universitá di Torino
Torino, Italy, 10126
Universitá degli Studi di Milano
Milano, Italy, 20122
University Federico II
Napoli, Italy, 80131
Netherlands
Dept. of Internal Medicine Erasmus MC
Rotterdam, Netherlands, 3015 GD
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Spain
Hospital General de Alicante
Alicante, Spain, 03012
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Clínica Puerta de Hierro
Madrid, Spain, 28035
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

No publications provided

Responsible Party: Ipsen ( Dr Pascal Birman )
Study ID Numbers: 2-55-52030-727
Study First Received: October 2, 2006
Last Updated: August 27, 2009
ClinicalTrials.gov Identifier: NCT00383708     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency;   France: Afssaps - French Health Products Safety Agency;   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:
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Antineoplastic Agents
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases
Angiopeptin
Cardiovascular Agents
Brain Diseases
Bone Diseases
Pharmacologic Actions
Lanreotide
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly

ClinicalTrials.gov processed this record on November 27, 2009