An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly (ACCESS)

Inclusion Criteria:

• Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (>ULN) and random GH (>1 μg/L) within 30 days of screening.
• Patients who are not controlled by pituitary surgery or who are not eligible for or refuse surgery.

• For patients on medical treatment for acromegaly the following washout periods must be completed before screening assessments are performed:

  • Dopamine agonists (bromocriptine, cabergoline): 4 weeks
  • GH-receptor antagonists (pegvisomant): 8 weeks
  • Somatostatin analogues: no washout period required
• Karnofsky performance status ≥ 60.

Exclusion Criteria:

• Concomitant treatment with somatostatin analogues unless concomitant treatment was discontinued 28 days before first pasireotide LAR injection is administrated.
• Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine agonists unless concomitant treatment was discontinued and the washout period was completed before the screening assessments are performed.
• Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
• Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
• Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening.
• Patients who have received radiotherapy of the pituitary within 4 weeks prior to screening or have not recovered from side effects of radiotherapy.
• Patients who have a history of hypothyroidism and who are not adequately treated with stable doses of thyroid hormone replacement therapy.
• Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).
• Diabetic patients whose blood glucose is poorly controlled.

Other protocol-defined inclusion/exclusion criteria may apply.