Tissue Biomarker for Pegvisomant Action

This study is currently recruiting participants.

Verified February 2012 by Cedars-Sinai Medical Center

First Received on December 15, 2010. Last Updated on February 6, 2012 History of Changes

Sponsor:	Cedars-Sinai Medical Center
Information provided by (Responsible Party):	William Gellepis, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01261000

Purpose

Acromegaly is a disease of the pituitary gland that involves the overproduction of growth hormone. The drug works by blocking the binding of growth hormone to growth hormone receptors found in tissues throughout the body. Human studies have evaluated the reduction of IGF-I levels in the blood following pegvisomant treatment, however, no studies have evaluated IGF-I levels in tissues following pegvisomant administration. In this study, we will test a novel tissue biomarker for pegvisomant action, distinct from measuring IGF-I levels in the blood. To this end, we will determine if administration of pegvisomant modifies the expression of IGF-I, IGF-I receptor, growth hormone receptor and GH- and IGF-i-dependent signaling molecules in the colon tissue of patients with acromegaly.

Condition	Intervention
Acromegaly	Drug: Pegvisomant

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tissue Biomarker for Pegvisomant Action

Resource links provided by NLM:

Drug Information available for: Pegvisomant

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Develop a tissue biomarker for pegvisomant action, other than serum IGF-I [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	November 2010
Estimated Primary Completion Date:	December 2012 (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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has provided written informed consent prior to any study related procedure
The patient age is between 18 and 80 years inclusive
The patient is male or female. If the woman is at risk of becoming pregnant, she must agree to use an effective method of contraception including implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261000

Contacts

Contact: Billy Gellepis	310-423-3395	Billy.Gellepis@cshs.org
Contact: Lori Korsakoff, RN	310-423-2411	lori.korsakoff@cshs.org

Locations

United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Shlomo Melmed, MD
Sub-Investigator: Magdalena Uhart, MD

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator:

Shlomo Melmed, MD

Cedars-Sinai Medical Center

More Information

No publications provided

Responsible Party:	William Gellepis, Research Administrator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01261000 History of Changes
Other Study ID Numbers:	23051, WS921563
Study First Received:	December 15, 2010
Last Updated:	February 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 May 23, 2012