Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383708
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: lanreotide (Autogel formulation) Drug: Pegvisomant Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Acromegaly symptoms [ Time Frame: 7 months ]
  2. Quality of life [ Time Frame: 7 months ]
  3. Adverse events, clinical evaluation, vital signs [ Time Frame: 7 months ]
  4. Glucose tolerance [ Time Frame: 7 months ]
  5. Standard haematology and biochemistry [ Time Frame: 7 months ]
  6. Gallbladder ultrasound [ Time Frame: 7 months ]
  7. Pituitary tumor size [ Time Frame: 7 months ]
  8. ECG [ Time Frame: 7 months ]
  9. Anti-lanreotide Autogel antibodies, anti-pegvisomant antibodies [ Time Frame: 7 months ]
  10. Lanreotide and pegvisomant serum levels (minimum observed concentrations Cmin) [ Time Frame: 7 months ]
  11. To assess the effect of lanreotide - pegvisomant co-administration on: GH, GH binding protein, acid labile subunit and prolactin levels [ Time Frame: 7 months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383708

Czech Republic
University Hospital, Charles University
Hradec Kralove, Czech Republic, 500 05
Charles University
Prague, Czech Republic, 120 00 PRAHA 2
Aarhus Kommunehospital
Aarhus, Denmark
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
Charite Campus Mitte
Berlin, Germany, 10117
Klinikum Johann Wolfgang Goethe-Universität
Frankfurt, Germany, 605090
Medizinische Klinik Innenstadt
Munchen, Germany, 80336
Anticancer Hospital Metaxa Piraeus
Piraeus, Greece, 18537
Universitá degli Studi di Milano
Milano, Italy, 20122
University Federico II
Napoli, Italy, 80131
Universitá di Torino
Torino, Italy, 10126
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Dept. of Internal Medicine Erasmus MC
Rotterdam, Netherlands, 3015 GD
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
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
Study Director: Pascal Birman, MD Ipsen

Publications of Results:
Responsible Party: Ipsen Identifier: NCT00383708     History of Changes
Other Study ID Numbers: 2-55-52030-727
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs