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