Tissue Biomarker for Pegvisomant Action

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shlomo Melmed, MD, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT01261000

First received: December 15, 2010

Last updated: February 2, 2015

Last verified: February 2015

History of Changes

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

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Further study details as provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:

Primary Outcome Measures:

Develop a tissue biomarker for pegvisomant action, other than serum IGF-I [ Time Frame: 1 year ]


Enrollment:	8
Study Start Date:	November 2010
Study Completion Date:	December 2013
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Shlomo Melmed, MD, Senior Vice President, Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01261000 History of Changes
Other Study ID Numbers:	23051 WS921563 ( Other Grant/Funding Number: Pfizer )
Study First Received:	December 15, 2010
Last Updated:	February 2, 2015

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 July 21, 2017

To Top