NCT01261000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 22, 2017

Completed
Last Updated

August 22, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

December 15, 2010

Results QC Date

April 18, 2017

Last Update Submit

July 23, 2017

Conditions

Acromegaly

Keywords

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • Effect of Pegvisomant on Colon Tissue p53 Expression

    Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

    8 weeks

Study Arms (1)

Pegvisomant

EXPERIMENTAL
Drug: Pegvisomant

Interventions

PegvisomantDRUG

Pegvisomant used as indicated

Also known as: Somavert
Pegvisomant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

  • 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.

    PMID: 27226307BACKGROUND

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Limitations and Caveats

Small sample size due to rare patient population

Results Point of Contact

Title
Vivian Hwe
Organization
Cedars-Sinai Medical Center
hwev@cshs.org
424-315-4489

Study Officials

  • Shlomo Melmed, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Vice President, Academic Affairs

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

August 22, 2017

Results First Posted

August 22, 2017

Record last verified: 2017-07

Locations

US(1)