for people ages 18 years and up (full criteria)
study started



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.

Official Title

An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS)


Acromegaly, Acromegaly, Pituitary diseases, Pasireotide, Pasireotide long acting release formulation


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.


  • University of California at Los Angeles UCLA - Los Angeles
    Los Angeles California 90095 United States
  • Harbor-UCLA Medical Center Center for Men's Health
    Torrance California 90509 United States
  • John Wayne Cancer Institute Saint John's Health Center
    Santa Monica California 90404 United States
  • University of Southern California Keck School of Medicine
    Los Angeles California 90033 United States
  • San Diego Coastal Endocrinology Group
    Chula Vista California 91911 United States


not accepting new patients
Start Date
Novartis Pharmaceuticals
Study Type
Expanded Access
Last Updated