Brief Title
Tissue Biomarker for Pegvisomant Action
Official Title
Tissue Biomarker for Pegvisomant Action
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.
Study Type
Interventional
Primary Outcome
Effect of Pegvisomant on Colon Tissue p53 Expression
Condition
Acromegaly
Intervention
Pegvisomant
Study Arms / Comparison Groups
Pegvisomant
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
November 2010
Completion Date
December 2013
Primary Completion Date
March 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Shlomo Melmed, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01261000
Organization ID
Pro23051
Secondary IDs
WS921563
Responsible Party
Principal Investigator
Study Sponsor
Cedars-Sinai Medical Center
Study Sponsor
Shlomo Melmed, MD, Principal Investigator, Cedars-Sinai Medical Center
Verification Date
July 2017