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

Acromegaly Clinical Trial

— ACCESS  

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)

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01995734
• Other study ID #: CSOM230CUS33
• Status: Approved for marketing
• Phase: N/A
• First received: November 20, 2013
• Last updated: December 26, 2015

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico School of Medicine Univ of NM	Albuquerque	New Mexico
United States	Emory University School of Medicine/Winship Cancer Institute Emory University (5)	Atlanta	Georgia
United States	Sinai Hospital of Baltimore Sinai Hospital, Baltimore	Baltimore	Maryland
United States	The Johns Hopkins University School of Medicine Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham Univ. of Alabama Birmingham	Birmingham	Alabama
United States	Tufts Medical Center Tufts Medical Ctr	Boston	Massachusetts
United States	Virginia Endocrinology Research	Chesapeake	Virginia
United States	Northwestern University Endo, Metabolism and Molecular	Chicago	Illinois
United States	San Diego Coastal Endocrinology Group	Chula Vista	California
United States	Dr. Steven Leichter, Endocrine Consultant	Columbus	Georgia
United States	Endocrinology Associates Inc	Columbus	Ohio
United States	Stony Brook Internists PC	East Setauket	New York
United States	Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2	Hollywood	Florida
United States	Baylor College of Medicine Division of Endocrinology	Houston	Texas
United States	PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc	Las Vegas	Nevada
United States	University of California at Los Angeles UCLA - Los Angeles	Los Angeles	California
United States	University of Southern California Keck School of Medicine	Los Angeles	California
United States	Central Florida Endocrine & Diabetes Consultants	Maitland	Florida
United States	MidState Endocrine Associates	Nashville	Tennessee
United States	Vanderbilt University Medical Center Clinical Trials Center	Nashville	Tennessee
United States	Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition	New Brunswick	New Jersey
United States	Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit	New York	New York
United States	Mount Sinai School of Medicine Mt. Sinai Schoof of Med.	New York	New York
United States	Endocrine Assoc of FL	Ocoee	Florida
United States	Advanced Research, LLC Advanced Reserch (4)	Peoria	Arizona
United States	Thomas Jefferson University Jefferson University Physician	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)	Phoenix	Arizona
United States	Allegheny Endocrinology Associates Allegheny Endo Associates	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University Oregon Health & Sciences	Portland	Oregon
United States	Mayo Clinic - Rochester Mayo Clinic (2)	Rochester	Minnesota
United States	John Wayne Cancer Institute Saint John's Health Center	Santa Monica	California
United States	Swedish Cancer Institute Swedish Neuroscience Institute	Seattle	Washington
United States	Endocrine Associates of Long Island, P.C.	Smithtown	New York
United States	Washington University	St. Louis	Missouri
United States	Toledo Clinic Toledo Clinic, Inc.	Toledo	Ohio
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States,