Tissue Biomarker for Pegvisomant Action

NCT ID: NCT01261000

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegvisomant

Group Type: EXPERIMENTAL

Pegvisomant

Intervention Type: DRUG

Pegvisomant used as indicated

Interventions

Pegvisomant

Pegvisomant used as indicated

Intervention Type: DRUG

Other Intervention Names

Somavert

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shlomo Melmed, MD

Executive Vice President, Academic Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shlomo Melmed, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

Chesnokova V, Zonis S, Zhou C, Recouvreux MV, Ben-Shlomo A, Araki T, Barrett R, Workman M, Wawrowsky K, Ljubimov VA, Uhart M, Melmed S. Growth hormone is permissive for neoplastic colon growth. Proc Natl Acad Sci U S A. 2016 Jun 7;113(23):E3250-9. doi: 10.1073/pnas.1600561113. Epub 2016 May 25.

Reference Type: BACKGROUND

PMID: 27226307 (View on PubMed)

Other Identifiers

WS921563

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro23051

Identifier Type: -

Identifier Source: org_study_id