Acromegaly Combination Treatment Study

NCT ID: NCT01538966

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-29
• Study Completion Date: 2022-05-20

Brief 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.

Detailed 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.

Conditions

Acromegaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose SRL + weekly Pegvisomant

High dose of SRL monthly

• Octreotide LAR 30mg
• Lanreotide 120mg

Weekly Pegvisomant (40-120mg/week)

Group Type: ACTIVE_COMPARATOR

Pegvisomant

Intervention Type: DRUG

Octreotide LAR

Intervention Type: DRUG

Lanreotide

Intervention Type: DRUG

Low dose SRL + daily Pegvisomant

Low dose of SRL monthly

• Octreotide LAR 10mg
• Lanreotide 60mg

Daily Pegvisomant (15-60mg/day)

Group Type: ACTIVE_COMPARATOR

Pegvisomant

Intervention Type: DRUG

Octreotide LAR

Intervention Type: DRUG

Lanreotide

Intervention Type: DRUG

Low dose SRL + weekly Pegvisomant

Low dose of SRL monthly

• Octreotide LAR 10mg
• Lanreotide 60mg

Weekly Pegvisomant (40-120mg/week)

Group Type: ACTIVE_COMPARATOR

Pegvisomant

Intervention Type: DRUG

Octreotide LAR

Intervention Type: DRUG

Lanreotide

Intervention Type: DRUG

Interventions

Pegvisomant

Intervention Type: DRUG

Octreotide LAR

Intervention Type: DRUG

Lanreotide

Intervention Type: DRUG

Other Intervention Names

Somavert; Sandostatin; Somatuline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 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

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.

Reference Type: RESULT

PMID: 32754748 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WS2036536

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro26424

Identifier Type: -

Identifier Source: org_study_id