Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
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.
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