Clinical trial NCT01995734: 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)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Acromegaly
Keywords: Acromegaly, Pituitary diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


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.

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