NCT00055302

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_2

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

3.5 years

First QC Date

February 25, 2003

Last Update Submit

August 31, 2015

Conditions

McCune-Albright Syndrome

Keywords

vaginal bleedingadvanced bone agefibrous dysplasiaMASMcCune-Albright Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: Arimidex 1 mg

Interventions

Arimidex 1 mgDRUG

Arimidex (anastrozole) 1mg once daily by mouth

1

Eligibility Criteria

AgeUp to 10 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Montpellier, France

Location

Research Site

Paris, France

Location

Research Site

Berlin, Germany

Location

Research Site

Erlangen, Germany

Location

Research Site

Osnabrück, Germany

Location

Research Site

Torino, Italy

Location

Research Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Fibrous Dysplasia, PolyostoticUterine HemorrhageFibrous Dysplasia of Bone

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Arimidex Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2003

First Posted

February 26, 2003

Study Start

August 1, 2002

Primary Completion

February 1, 2006

Study Completion

August 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

IT(1)FR(2)DE(3)GB(1)