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Arimidex in McCune Albright Syndrome

Primary Purpose

McCune-Albright Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Arimidex 1 mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for McCune-Albright Syndrome focused on measuring vaginal bleeding, advanced bone age, fibrous dysplasia, MAS, McCune-Albright Syndrome

Eligibility Criteria

undefined - 10 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity

Secondary Outcome Measures

Full Information

First Posted
February 25, 2003
Last Updated
August 31, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00055302
Brief Title
Arimidex in McCune Albright Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
McCune-Albright Syndrome
Keywords
vaginal bleeding, advanced bone age, fibrous dysplasia, MAS, McCune-Albright Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Arimidex 1 mg
Intervention Description
Arimidex (anastrozole) 1mg once daily by mouth
Primary Outcome Measure Information:
Title
The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity
Time Frame
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

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Arimidex Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Erlangen
Country
Germany
Facility Name
Research Site
City
Osnabrück
Country
Germany
Facility Name
Research Site
City
Torino
Country
Italy
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1503&filename=CSR-1033IL-0046.pdf
Description
CSR-1033IL-0046.pdf

Learn more about this trial

Arimidex in McCune Albright Syndrome

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