Back to resultsTissue Biomarker for Pegvisomant Action
Primary Purpose
Acromegaly
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pegvisomant
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly
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
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pegvisomant
Arm Description
Outcomes
Primary Outcome Measures
Effect of Pegvisomant on Colon Tissue p53 Expression
Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant
Secondary Outcome Measures
Full Information
NCT ID
NCT01261000
First Posted
December 15, 2010
Last Updated
July 23, 2017
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01261000
Brief Title
Tissue Biomarker for Pegvisomant Action
Official Title
Tissue Biomarker for Pegvisomant Action
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegvisomant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Other Intervention Name(s)
Somavert
Intervention Description
Pegvisomant used as indicated
Primary Outcome Measure Information:
Title
Effect of Pegvisomant on Colon Tissue p53 Expression
Description
Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomo Melmed, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27226307
Citation
Chesnokova V, Zonis S, Zhou C, Recouvreux MV, Ben-Shlomo A, Araki T, Barrett R, Workman M, Wawrowsky K, Ljubimov VA, Uhart M, Melmed S. Growth hormone is permissive for neoplastic colon growth. Proc Natl Acad Sci U S A. 2016 Jun 7;113(23):E3250-9. doi: 10.1073/pnas.1600561113. Epub 2016 May 25. Erratum In: Proc Natl Acad Sci U S A. 2016 Aug 30;113(35):E5251.
Results Reference
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Tissue Biomarker for Pegvisomant Action
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