Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly (MACS0709)

• Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Measure the tumor volume reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

• Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Measure the tumor size reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

• Drug: Pasireotide (SOM230)
• Drug: octreotide LAR 30mg
• Drug: lanreotide ATG 120mg

• Experimental: Pasireotide LAR 40 mg
  Intervention: Drug: Pasireotide (SOM230)
• Experimental: Pasireotide LAR 60 mg
  Intervention: Drug: Pasireotide (SOM230)
• Active Comparator: Control arm (octreotide or lanreotide)
  Interventions:

  • Drug: octreotide LAR 30mg
  • Drug: lanreotide ATG 120mg

Inclusion Criteria:

1. Patients with written informed consent prior to any study related activity
2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg
4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

1. Patients who have received pasireotide (SOM 230) prior to enrolment
2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects
4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
5. Patients who have received pituitary irradiation within 10 years prior to visit 1 (screening).
6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply