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

December 26, 2015 updated by: Novartis Pharmaceuticals

An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS)

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 26, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230CUS33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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