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

Novartis Pharmaceuticals

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

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)
Brief Summary: 
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.
Approved for marketing
Acromegaly

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

Eligibility Criteria: 

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.

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Countries: 
United States
Locations: 

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

Novartis Pharmaceuticals
EA Number: 
Keywords: 
Acromegaly, Pituitary diseases
MeSH Terms: 
Acromegaly, Pasireotide
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