Tissue Biomarker for Pegvisomant Action

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261000
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Shlomo Melmed, MD, Cedars-Sinai Medical Center

Brief Summary:
Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.

Condition or disease Intervention/treatment
Acromegaly Drug: Pegvisomant

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Biomarker for Pegvisomant Action
Study Start Date : November 2010
Primary Completion Date : March 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pegvisomant
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pegvisomant Drug: Pegvisomant
Pegvisomant used as indicated
Other Name: Somavert

Primary Outcome Measures :
  1. Effect of Pegvisomant on Colon Tissue p53 Expression [ Time Frame: 8 weeks ]
    Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (>1.3 X ULN), and inadequate GH suppression (>0.4 ng/mL) following OGTT
  • Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
  • Normal LFTs before treatment
  • Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement

Exclusion Criteria:

  • Treatment with a long-acting SRL within 12 weeks before enrollment
  • Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
  • Clinically significant hepatic abnormalities and/or AST or ALT >3 X ULN on screening
  • Known hypersensitivity to any of the test materials or related compounds
  • History of, or known current, problems with alcohol or drug abuse
  • Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261000

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center

Responsible Party: Shlomo Melmed, MD, Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center Identifier: NCT01261000     History of Changes
Other Study ID Numbers: Pro23051
WS921563 ( Other Grant/Funding Number: Pfizer )
First Posted: December 16, 2010    Key Record Dates
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: July 2017

Keywords provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases