Tissue Biomarker for Pegvisomant Action

NCTNCT01261000Other idPro23051Other idWS921563

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 8 participants (actual)
Sponsor: Cedars-Sinai Medical Center · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2010
Primary completion: Mar 2013
Completion: Dec 2013
First posted: 16 Dec 2010 (estimated)
Last update posted: 22 Aug 2017
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102011201220132014

N/A
Tissue Biomarker for Pegvisomant Action
NCT01261000
Nov 2010 to Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PegvisomantDrug

Arms1

Experimental
Pegvisomant

Primary outcomes1

Outcomes the sponsor listed as primary.

Effect of Pegvisomant on Colon Tissue p53 Expression
Time frame · 8 weeks
Registry description
Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 8 weeks

Effect of Pegvisomant on Colon Tissue p53 Expression

Group	Value (ng/mL)	Spread
Pegvisomant	330.57	107.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PegvisomantPegvisomant: Pegvisomant used as indicated	0 / 8	1 / 8	0 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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