Acromegaly Combination Treatment Study

  • STATUS
    Recruiting
  • End date
    Jun 4, 2022
  • participants needed
    76
  • sponsor
    Cedars-Sinai Medical Center
Updated on 4 October 2021
octreotide
dopamine
medical therapy
combination therapy
pituitary
somatomedin c
lanreotide
somatostatin
pegvisomant
hepatic disease
insulin-like growth factor
dopamine agonists
igf1
lfts

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 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 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. An MRI will be performed at the conclusion of the study.

Details
Condition Acromegaly
Treatment pegvisomant, Lanreotide, Somatostatin Receptor Ligand (SRL), Octreotide LAR
Clinical Study IdentifierNCT01538966
SponsorCedars-Sinai Medical Center
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

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
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