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

Novartis

Status

Conditions: Acromegaly

Treatments: Drug: Pasireotide long acting release formulation

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01995734

CSOM230CUS33

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.