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

October 2, 2006
June 18, 2012
October 2006
October 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00383708 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the effect of lanreotide - pegvisomant co-administration on:
  • Acromegaly symptoms
  • Quality of life
  • Safety based on:
  • Adverse events, clinical evaluation, vital signs
  • Glucose tolerance
  • Standard haematology and biochemistry
  • Gallbladder ultrasound
  • Pituitary tumor size
  • ECG
  • Anti-lanreotide Autogel antibodies, anti-pegvisomant antibodies
  • Lanreotide and pegvisomant serum levels (minimum observed concentrations Cmin)
  • Additional Study Objectives:
  • To assess the effect of lanreotide - pegvisomant co-administration on: GH, GH binding protein, acid labile subunit and prolactin levels
Not Provided
Not Provided
 
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
  • 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.
Experimental: 1
Interventions:
  • Drug: lanreotide (Autogel formulation)
  • Drug: Pegvisomant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Greece,   Germany,   Czech Republic,   United Kingdom,   France,   Spain,   Netherlands,   Sweden,   Italy
 
NCT00383708
2-55-52030-727
No
Ipsen
Ipsen
Not Provided
Study Director: Pascal Birman, MD Ipsen
Ipsen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP