Acromegaly Combination Treatment Study

  • STATUS
    Recruiting
  • participants needed
    76
  • sponsor
    Cedars-Sinai Medical Center
Updated on 1 July 2022
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 on1 July 2022

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