Acromegaly Combination Treatment Study

Acromegaly Clinical Trial

Official title:

Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01538966
• Other study ID #: Pro26424
• Secondary ID: WS2036536
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acromegaly

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