Overview

Faslodex in McCune Albright Syndrome

Status:
Active, not recruiting
Trial end date:
2023-07-03
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome (MAS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Fulvestrant
Criteria
Inclusion Criteria:

- Females less than or equal to 10 years of age (prior to 11th birthday)

- Diagnosis of McCune-Albright syndrome (MAS)

- Progressive precocious puberty (PPP) associated with MAS

Exclusion Criteria:

- Received any prior treatment for PPP associated with MAS with fulvestrant

- Abnormal platelet count or liver function tests

- Bleeding disorders

- Long term anticoagulation therapy

- Known hypersensitivity to any component of the study drug