The present study is planned as an expanded treatment protocol to provide acromegalicpatients for whom medical therapy is appropriate access to pasireotide LAR whileregulatory 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, 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, 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
Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
New York, New York, United States
Endocrine Associates of Long Island, P.C.
Smithtown, New York, United States
Endocrinology Associates Inc
Columbus, Ohio, United States
Toledo Clinic Toledo Clinic, Inc.
Toledo, Ohio, United States
Oregon Health & Sciences University Oregon Health & Sciences
Portland, Oregon, United States
Thomas Jefferson University Jefferson University Physician
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates Allegheny Endo Associates
Pittsburgh, Pennsylvania, United States
MidState Endocrine Associates
Nashville, Tennessee, United States
Vanderbilt University Medical Center Clinical Trials Center
Nashville, Tennessee, United States
Baylor College of Medicine Division of Endocrinology
Houston, Texas, United States
Virginia Endocrinology Research
Chesapeake, Virginia, United States
Swedish Cancer Institute Swedish Neuroscience Institute
Seattle, Washington, United States
Novartis Pharmaceuticals, Study Director
Novartis Pharmaceuticals