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
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