AcromegalyNCT01261000

Tissue Biomarker for Pegvisomant Action

A study testing Pegvisomant in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acromegaly
What is being tested?: Pegvisomant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

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
Being tested: Pegvisomant
Keywords: Acromegaly
Medical subject headings: Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegvisomantDrug
Also called Somavert
Pegvisomant used as indicated

Study groups in NCT01261000
Study group	Role	What they receive
Pegvisomant	Experimental	Not described Receives: Drug: Pegvisomant

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Dec 2013

First posted16 Dec 2010 (estimated)
Study startNov 2010
Primary completionMar 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AcromegalyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01261000
Sponsor's protocol ID: Pro23051
Other IDs: WS921563
Status last verified: Jul 2017
First submitted: 15 Dec 2010
Last updated: 22 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27226307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tissue Biomarker for Pegvisomant Action
ClinicalTrials.gov ID: NCT01261000
Acronym / sponsor ID: Pro23051
Conditions: Acromegaly
Keywords: Acromegaly
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: Nov 2010
Primary completion: Mar 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Dec 2010 (estimated)
Results: Posted 22 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pegvisomant	Experimental	Drug: Pegvisomant

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegvisomantAlso: SomavertPegvisomant used as indicated	Drug	Pegvisomant

Primary outcome

Effect of Pegvisomant on Colon Tissue p53 Expression
Time frame: 8 weeks
Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Results and safety

Results posted to the registry on 22 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pegvisomant	8	7

Primary outcome: Effect of Pegvisomant on Colon Tissue p53 Expression

Time frame: 8 weeks. Mean (Standard Deviation). Unit: ng/mL

Measure	Pegvisomant n = 7
Value	330.57 (107.33)

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pegvisomant	1 of 8 (12.5%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): Small sample size due to rare patient population

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27226307Chesnokova 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.

Related trials for Acromegaly

RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shlomo Melmed, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pegvisomant in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Pegvisomant on Colon Tissue p53 Expression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261000, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.