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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01538966
Other study ID # Pro26424
Secondary ID WS2036536
Status Terminated
Phase N/A
First received
Last updated
Start date March 29, 2012
Est. completion date May 20, 2022

Study information

Verified date August 2022
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.


Description:

Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms. The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from the start of the study. However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility. After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start pegvisomant monotherapy at the same dose and schedule that they attained normalization in combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.


Recruitment information / eligibility

Status Terminated
Enrollment 76
Est. completion date May 20, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Newly diagnosed patients with acromegaly who have not had surgery or medical therapy - Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy - Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels - Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels. - Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist. - Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly - Normal liver function tests before randomization to treatment - The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy. Exclusion Criteria: - The patient harbors a macroadenoma with visual field defects due to chiasmatic compression - The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit. - The patient had pituitary surgery within 3 months prior to study entry - The patient had radiotherapy within 12 months prior to study entry - The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety. - The patient has a known hypersensitivity to any of the test materials or related compounds. - The patient has a history of, or known current problems with alcohol or drug abuse. - The patient has 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pegvisomant

Octreotide LAR

Lanreotide


Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bonert V, Mirocha J, Carmichael J, Yuen KCJ, Araki T, Melmed S. Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa444. doi: 10.1210/clinem/dgaa444. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cost Effectiveness We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels. 24 weeks
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