Tissue Biomarker for Pegvisomant Action

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Acromegaly
Related Access Program
Novartis Pharmaceuticals – Acromegaly
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Brief Title

Tissue Biomarker for Pegvisomant Action

Official Title

Tissue Biomarker for Pegvisomant Action

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.

Study Type

Interventional

Primary Outcome

Effect of Pegvisomant on Colon Tissue p53 Expression

Condition

Acromegaly

Intervention

Pegvisomant

Study Arms / Comparison Groups

 Pegvisomant
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

8

Start Date

November 2010

Completion Date

December 2013

Primary Completion Date

March 2013

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

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Shlomo Melmed, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01261000

Organization ID

Pro23051

Secondary IDs

WS921563

Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center

Study Sponsor

Shlomo Melmed, MD, Principal Investigator, Cedars-Sinai Medical Center

Verification Date

July 2017