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

APPROVED_FOR_MARKETING

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT01995734

Run by

Novartis Pharmaceuticals

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• University of Alabama at Birmingham Univ. of Alabama Birmingham — Birmingham, Alabama, United States
• Advanced Research, LLC Advanced Reserch (4) — Peoria, Arizona, United States
• St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2) — Phoenix, Arizona, United States
• San Diego Coastal Endocrinology Group — Chula Vista, California, United States
• University of Southern California Keck School of Medicine — Los Angeles, California, United States
• University of California at Los Angeles UCLA - Los Angeles — Los Angeles, California, United States
• John Wayne Cancer Institute Saint John's Health Center — Santa Monica, California, United States
• Harbor-UCLA Medical Center Center for Men's Health — Torrance, California, United States
• George Washington University Medical Center Medical Faculty Associates Inc — Washington D.C., District of Columbia, United States
• Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2 — Hollywood, Florida, United States
• Central Florida Endocrine & Diabetes Consultants — Maitland, Florida, United States
• Endocrine Assoc of FL — Ocoee, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Emory University (5) — Atlanta, Georgia, United States
• Dr. Steven Leichter, Endocrine Consultant — Columbus, Georgia, United States
• Northwestern University Endo, Metabolism and Molecular — Chicago, Illinois, United States
• The Johns Hopkins University School of Medicine Johns Hopkins University — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore Sinai Hospital, Baltimore — Baltimore, Maryland, United States
• Tufts Medical Center Tufts Medical Ctr — Boston, Massachusetts, United States
• Mayo Clinic - Rochester Mayo Clinic (2) — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc — Las Vegas, Nevada, United States
• Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition — New Brunswick, New Jersey, United States
• University of New Mexico School of Medicine Univ of NM — Albuquerque, New Mexico, United States
• Stony Brook Internists PC — East Setauket, New York, United States
• Mount Sinai School of Medicine Mt. Sinai Schoof of Med. — New York, New York, United States

Full record on ClinicalTrials.gov

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