Arimidex in McCune Albright Syndrome

McCune-Albright Syndrome Clinical Trial

Official title:

An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055302
• Other study ID #: 1033IL/0046
• Secondary ID: D5394C00046
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2003
• Last updated: August 31, 2015
• Start date: August 2002
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 10 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• McCune-Albright Syndrome
• Syndrome

Intervention

Drug:
• Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth

Locations

Country	Name	City	State
France	Research Site	Montpellier
France	Research Site	Paris
Germany	Research Site	Berlin
Germany	Research Site	Erlangen
Germany	Research Site	Osnabrück
Italy	Research Site	Torino
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity		12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal	No

External Links

•   CSR-1033IL-0046.pdf