An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
The present study is planned as an expanded treatment protocol to provide acromegalic
 patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory
 approval for pasireotide is sought.
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.