Overview

Arimidex in McCune Albright Syndrome

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Anastrozole
Criteria
Inclusion Criteria:

- informed written consent of parent/legal guardian and subject assent (as needed by
local requirements)

- females less than or equal to 10 years of age

- diagnosed with McCune-Albright Syndrome

- have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from
the study:

- any prior treatment of MAS associated with progressive precocious puberty with a third
generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no
clinical response was seen

- concomitant treatment of precocious puberty associated with MAS, with the exception of
bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of
central precocious puberty

- liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the
reference range for age

- known hypersensitivity to any component of study medication