drugset / Trial / NCT01620138

Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

NCT01620138

Phase 2/3 Completed 21 enrolled Federal University of Rio de Janeiro
RandomizedParallel-groupOpen-labelTreatment

Summary

There are no available medical treatment options for patients with non-functioning pituitary adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA) expression levels and immunohistochemistry analysis might end with a better understanding of these tumors. Besides that, it will be assessed the in vitro and in vivo responses to pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be compared with the receptor expressions which may be a tool as a predicting element of the response to these compounds.

Timeline

Start
2010-03
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabergoline Small molecule 3 mg
Comparator Pasireotide Other / unclassified 600 ug Subcutaneous
Comparator Pasireotide Other / unclassified 900 ug Subcutaneous