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

Primary Purpose

Acromegaly

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Pasireotide long acting release formulation
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Acromegaly focused on measuring Acromegaly, Pituitary diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham Univ. of Alabama Birmingham
  • Advanced Research, LLC Advanced Reserch (4)
  • St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)
  • San Diego Coastal Endocrinology Group
  • University of Southern California Keck School of Medicine
  • University of California at Los Angeles UCLA - Los Angeles
  • John Wayne Cancer Institute Saint John's Health Center
  • Harbor-UCLA Medical Center Center for Men's Health
  • George Washington University Medical Center Medical Faculty Associates Inc
  • Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2
  • Central Florida Endocrine & Diabetes Consultants
  • Endocrine Assoc of FL
  • Emory University School of Medicine/Winship Cancer Institute Emory University (5)
  • Dr. Steven Leichter, Endocrine Consultant
  • Northwestern University Endo, Metabolism and Molecular
  • The Johns Hopkins University School of Medicine Johns Hopkins University
  • Sinai Hospital of Baltimore Sinai Hospital, Baltimore
  • Tufts Medical Center Tufts Medical Ctr
  • Mayo Clinic - Rochester Mayo Clinic (2)
  • Washington University
  • PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc
  • Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition
  • University of New Mexico School of Medicine Univ of NM
  • Stony Brook Internists PC
  • Mount Sinai School of Medicine Mt. Sinai Schoof of Med.
  • Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
  • Endocrine Associates of Long Island, P.C.
  • Endocrinology Associates Inc
  • Toledo Clinic Toledo Clinic, Inc.
  • Oregon Health & Sciences University Oregon Health & Sciences
  • Thomas Jefferson University Jefferson University Physician
  • Allegheny Endocrinology Associates Allegheny Endo Associates
  • MidState Endocrine Associates
  • Vanderbilt University Medical Center Clinical Trials Center
  • Baylor College of Medicine Division of Endocrinology
  • Virginia Endocrinology Research
  • Swedish Cancer Institute Swedish Neuroscience Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 20, 2013
Last Updated
December 26, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01995734
Brief Title
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
Acronym
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)
Study Type
Expanded Access

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, Pituitary diseases

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pasireotide long acting release formulation
Other Intervention Name(s)
SOM230 LAR
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Univ. of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Advanced Research, LLC Advanced Reserch (4)
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
San Diego Coastal Endocrinology Group
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
University of Southern California Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California at Los Angeles UCLA - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
John Wayne Cancer Institute Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Harbor-UCLA Medical Center Center for Men's Health
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
George Washington University Medical Center Medical Faculty Associates Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Central Florida Endocrine & Diabetes Consultants
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Endocrine Assoc of FL
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Emory University School of Medicine/Winship Cancer Institute Emory University (5)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dr. Steven Leichter, Endocrine Consultant
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Northwestern University Endo, Metabolism and Molecular
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3308
Country
United States
Facility Name
The Johns Hopkins University School of Medicine Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Sinai Hospital of Baltimore Sinai Hospital, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Tufts Medical Center Tufts Medical Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic - Rochester Mayo Clinic (2)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico School of Medicine Univ of NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Stony Brook Internists PC
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Mount Sinai School of Medicine Mt. Sinai Schoof of Med.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Endocrine Associates of Long Island, P.C.
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Endocrinology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
Columbus
Country
United States
Facility Name
Toledo Clinic Toledo Clinic, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Oregon Health & Sciences University Oregon Health & Sciences
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University Jefferson University Physician
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Endocrinology Associates Allegheny Endo Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
MidState Endocrine Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center Clinical Trials Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-3139
Country
United States
Facility Name
Baylor College of Medicine Division of Endocrinology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Endocrinology Research
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Swedish Cancer Institute Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30899469
Citation
Jerkins TW, Jerkins RK, Franklin R. Successful debulking of plurihormonal pituitary macroadenoma with long-acting pasireotide and dopamine agonist combination therapy. Clin Case Rep. 2019 Jan 28;7(3):445-451. doi: 10.1002/ccr3.1961. eCollection 2019 Mar.
Results Reference
derived
PubMed Identifier
29925553
Citation
Lovato CM, Kapsner PL. Analgesic effect of long-acting somatostatin receptor agonist pasireotide in a patient with acromegaly and intractable headaches. BMJ Case Rep. 2018 Jun 19;2018:bcr2017219686. doi: 10.1136/bcr-2017-219686.
Results Reference
derived
PubMed Identifier
28025627
Citation
Gordon MB, Nakhle S, Ludlam WH. Patients with Acromegaly Presenting with Colon Cancer: A Case Series. Case Rep Endocrinol. 2016;2016:5156295. doi: 10.1155/2016/5156295. Epub 2016 Nov 29.
Results Reference
derived
PubMed Identifier
27896545
Citation
Fleseriu M, Rusch E, Geer EB; ACCESS Study Investigators. Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study. Endocrine. 2017 Jan;55(1):247-255. doi: 10.1007/s12020-016-1182-4. Epub 2016 Nov 28.
Results Reference
derived

Learn more about this trial

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

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