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Tissue Biomarker for Pegvisomant Action
This study has been completed.
Sponsor:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Shlomo Melmed, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01261000
First received: December 15, 2010
Last updated: July 23, 2017
Last verified: July 2017
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Purpose
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 | Intervention |
|---|---|
| Acromegaly | Drug: Pegvisomant |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Tissue Biomarker for Pegvisomant Action |
Resource links provided by NLM:
Further study details as provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:
Primary Outcome Measures:
- 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
| Enrollment: | 8 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pegvisomant |
Drug: Pegvisomant
Pegvisomant used as indicated
Other Name: Somavert
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01261000
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261000
Locations
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
| Principal Investigator: | Shlomo Melmed, MD | Cedars-Sinai Medical Center |
More Information
Publications:
| Responsible Party: | Shlomo Melmed, MD, Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT01261000 History of Changes |
| Other Study ID Numbers: |
Pro23051 WS921563 ( Other Grant/Funding Number: Pfizer ) |
| Study First Received: | December 15, 2010 |
| Results First Received: | April 18, 2017 |
| Last Updated: | July 23, 2017 |
Keywords provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:
|
Acromegaly |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017