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.
Drug: Pasireotide long acting release formulation
Pasireotide LAR will be administered intramuscularly (i.m.) every 28 days until pasireotide becomes commercially available and reimbursed or until 31 December 2015, whichever occurs first.
Other Name: SOM230 LAR
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.
University of Alabama at Birmingham Univ. of Alabama Birmingham
Birmingham, Alabama, 35294
Advanced Research, LLC Advanced Reserch (4)
Peoria, Arizona, 85381
St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)
Phoenix, Arizona, 85013
San Diego Coastal Endocrinology Group
Chula Vista, California, 91911
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
University of California at Los Angeles UCLA - Los Angeles
Los Angeles, California, 90095
John Wayne Cancer Institute Saint John's Health Center
Santa Monica, California, 90404
Harbor-UCLA Medical Center Center for Men's Health
Torrance, California, 90509
George Washington University Medical Center Medical Faculty Associates Inc
Washington, District of Columbia, 20037
Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2
Hollywood, Florida, 33021
Central Florida Endocrine & Diabetes Consultants
Maitland, Florida, 32751
Endocrine Assoc of FL
Ocoee, Florida, 34761
Emory University School of Medicine/Winship Cancer Institute Emory University (5)
Atlanta, Georgia, 30322
Dr. Steven Leichter, Endocrine Consultant
Columbus, Georgia, 31901
Northwestern University Endo, Metabolism and Molecular
Chicago, Illinois, 60611-3308
The Johns Hopkins University School of Medicine Johns Hopkins University
Baltimore, Maryland, 21205
Sinai Hospital of Baltimore Sinai Hospital, Baltimore
Baltimore, Maryland, 21215
Tufts Medical Center Tufts Medical Ctr
Boston, Massachusetts, 02111
Mayo Clinic - Rochester Mayo Clinic (2)
Rochester, Minnesota, 55905
Washington University
St. Louis, Missouri, 63110
PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc
Las Vegas, Nevada, 89148
Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition
New Brunswick, New Jersey, 08903
University of New Mexico School of Medicine Univ of NM
Albuquerque, New Mexico, 87131
Stony Brook Internists PC
East Setauket, New York, 11733
Mount Sinai School of Medicine Mt. Sinai Schoof of Med.
New York, New York, 10029
Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
New York, New York, 10032
Endocrine Associates of Long Island, P.C.
Smithtown, New York, 11787
Endocrinology Associates Inc
Columbus, Ohio, Columbus
Toledo Clinic Toledo Clinic, Inc.
Toledo, Ohio, 43623
Oregon Health & Sciences University Oregon Health & Sciences
Portland, Oregon, 97239
Thomas Jefferson University Jefferson University Physician
Philadelphia, Pennsylvania, 19107
Allegheny Endocrinology Associates Allegheny Endo Associates
Pittsburgh, Pennsylvania, 15212
MidState Endocrine Associates
Nashville, Tennessee, 37203
Vanderbilt University Medical Center Clinical Trials Center
Nashville, Tennessee, 37212-3139
Baylor College of Medicine Division of Endocrinology
Houston, Texas, 77030
Virginia Endocrinology Research
Chesapeake, Virginia, 23321
Swedish Cancer Institute Swedish Neuroscience Institute
Seattle, Washington, 98104
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals