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AcromegalyACCESSNCT01995734

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

A study testing Pasireotide long acting release formulation in people with Acromegaly, run by Novartis Pharmaceuticals at 37 sites in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
What is being tested?
Pasireotide long acting release formulation
Type of treatment
Injection or infusion
How many people
Not given
Where
37 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • University of New Mexico School of Medicine Univ of NM

    Albuquerque, New Mexico, 87131

  • Emory University School of Medicine/Winship Cancer Institute Emory University (5)

    Atlanta, Georgia, 30322

  • The Johns Hopkins University School of Medicine Johns Hopkins University

    Baltimore, Maryland, 21205

  • Sinai Hospital of Baltimore Sinai Hospital, Baltimore

    Baltimore, Maryland, 21215

  • University of Alabama at Birmingham Univ. of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center Tufts Medical Ctr

    Boston, Massachusetts, 02111

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321

  • Northwestern University Endo, Metabolism and Molecular

    Chicago, Illinois, 60611-3308

  • San Diego Coastal Endocrinology Group

    Chula Vista, California, 91911

  • Dr. Steven Leichter, Endocrine Consultant

    Columbus, Georgia, 31901

  • Endocrinology Associates Inc

    Columbus, Ohio, Columbus

  • Stony Brook Internists PC

    East Setauket, New York, 11733

  • Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2

    Hollywood, Florida, 33021

  • Baylor College of Medicine Division of Endocrinology

    Houston, Texas, 77030

  • PALM MEDICAL RESEARCH CENTER Palm Research Center, Inc

    Las Vegas, Nevada, 89148

  • 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

  • Central Florida Endocrine & Diabetes Consultants

    Maitland, Florida, 32751

  • MidState Endocrine Associates

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center Clinical Trials Center

    Nashville, Tennessee, 37212-3139

  • Robert Wood Johnson Medical School Div. Endo, Meta & Nutrition

    New Brunswick, New Jersey, 08903

  • 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 Assoc of FL

    Ocoee, Florida, 34761

  • Advanced Research, LLC Advanced Reserch (4)

    Peoria, Arizona, 85381

  • Thomas Jefferson University Jefferson University Physician

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)

    Phoenix, Arizona, 85013

  • Allegheny Endocrinology Associates Allegheny Endo Associates

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health & Sciences University Oregon Health & Sciences

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester Mayo Clinic (2)

    Rochester, Minnesota, 55905

  • John Wayne Cancer Institute Saint John's Health Center

    Santa Monica, California, 90404

  • Swedish Cancer Institute Swedish Neuroscience Institute

    Seattle, Washington, 98104

  • Endocrine Associates of Long Island, P.C.

    Smithtown, New York, 11787

  • Washington University

    St Louis, Missouri, 63110

  • Toledo Clinic Toledo Clinic, Inc.

    Toledo, Ohio, 43623

  • Harbor-UCLA Medical Center Center for Men's Health

    Torrance, California, 90509

  • George Washington University Medical Center Medical Faculty Associates Inc

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

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)

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.

Conditions
Acromegaly
Being tested
Pasireotide long acting release formulation
Keywords
Acromegaly, Pituitary diseases
Medical subject headings
Acromegaly, Pituitary Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pasireotide long acting release formulationDrug

    Also called SOM230 LAR

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01995734
Sponsor's protocol ID
CSOM230CUS33
Acronym
ACCESS
Status last verified
Dec 2015
First submitted
20 Nov 2013
Last updated
29 Dec 2015
Results posted
No

Publications

  • 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.

    PubMed 30899469

  • 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.

    PubMed 29925553

  • 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.

    PubMed 28025627

  • 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.

    PubMed 27896545

Questions about this trial

What is this clinical trial studying?

A study testing Pasireotide long acting release formulation in people with Acromegaly, run by Novartis Pharmaceuticals at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995734, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.

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