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Hormone Therapy

Fulvestrant for McCune Albright Syndrome (FMAS Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period)

Awards & highlights

FMAS Trial Summary

This trial will study the effects of Faslodex on young girls with MAS who are experiencing precocious puberty.

Eligible Conditions

McCune Albright Syndrome
Precocious Puberty

FMAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change Mean in Ovarian Volume From Month 6 to Month 12/Final Visit as Assessed by Ultrasound

Change in Frequency of Annualized Days of Vaginal Bleeding on Treatment Compared to Baseline

Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over First 6-month Treatment Period Compared to Baseline

+27 more

Secondary outcome measures

Change in Predicted Adult Height (PAH) From Baseline to Month 12/Final Visit

Change in Tanner Stage of Breast From Baseline to Month 12/Final Visit

Change in Tanner Stage of Pubic Hair From Baseline to Month 12/Final Visit

+1 more

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698

12%

Arthralgia

11%

Fatigue

Nausea

Hot flush

Constipation

Diarrhoea

Urinary tract infection

Dyspnoea

Vomiting

Cough

Back pain

Musculoskeletal pain

Femur Fracture

Renal Failure

Cardiac Failure

Pulmonary Embolism

Pleural Effusion

Pneumonia

Sepsis

Back Pain

Dizziness

Syncope

Infection

100%

80%

60%

40%

20%

Study treatment Arm

Fulvestrant + Anastrozole

Anastrozole

FMAS Trial Design

1Treatment groups

Experimental Treatment

Group I: FulvestrantExperimental Treatment1 Intervention

Participants will receive intramuscular injection of fulvestrant 2 mg/kg or 4 mg/kg (First 10 participants will be dosed at 2 mg/kg then increased to 4 mg/kg. All subsequent participants will be dosed at 4 mg/kg) into the buttock or thigh monthly for 12 months or until the participant demonstrates lack of efficacy based upon one or more of the primary endpoints or experiences a serious drug-related toxicity requiring treatment discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,265 Previous Clinical Trials

288,605,252 Total Patients Enrolled

1 Trials studying McCune Albright Syndrome

40 Patients Enrolled for McCune Albright Syndrome

AstraZeneca Faslodex Medical Science Director, MDStudy DirectorAstraZeneca

4 Previous Clinical Trials

1,198 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research restricted to individuals under the age of 45?

"The set boundaries of this trial mandate that all participants be between one and ten years old."

Answered by AI

To what degree has Fulvestrant been explored in the literature?

"At present, 133 clinical studies are underway researching fulvestrant; 32 of these active trials have reached Phase 3. Primarily hosted in Shanghai, there are 5794 sites globally conducting this investigation."

Answered by AI

What is the total cohort of participants for this research endeavor?

"Unfortunately, this research project is no longer recruiting volunteers. It was first posted on January 31st 2006 and last modified September 15th 2022. There are currently 1389 trials for MCCune Albright Syndrome and 133 studies using Fulvestrant actively accepting participants if you wish to explore other options."

Answered by AI

Is it still feasible for a person to join this research trial?

"Unfortunately, this experiment is not presently recruiting any test subjects. It was first listed on January 31st 2006 and had its last update on September 15th 2022. If you wish to participate in other trials there are 1389 clinical studies for McCune Albright Syndrome and 133 for Fulvestrant currently open for recruitment."

Answered by AI

How extensive is the availability of this medical research in our state?

"This clinical trial is running in 15 different locations across the US, such as Bronx, Kansas City and Portland. To minimize travel demands, it's prudent to select a site closest to you if you decide to join this study."

Answered by AI

What safety measures are taken with the administration of Fulvestrant?

"Though there is limited clinical data on its efficacy, Fulvestrant has been assigned a safety score of 2 due to the evidence that exists in support of it."

Answered by AI

What conditions is Fulvestrant commonly prescribed to alleviate?

"Commonly used to treat endocrine diseases, fulvestrant has also proven beneficial in combating breast cancer and pik3ca gene mutations."

Answered by AI

Do I fulfill the criteria necessary to join this research endeavor?

"This medical trial is seeking 30 individuals with mccune albright syndrome aged between 1 year and 10 years. Qualifying candidates may be accepted into the experiment."

Answered by AI

Recent research and studies

International Journal of Pediatric EndocrinologyJournal

Fulvestrant Treatment of Precocious Puberty in Girls with Mccune-albright Syndrome

Sims, Emily K, Sally Garnett, Franco Guzman, Françoise Paris, Charles Sultan, and Erica A Eugster. 2012. “Fulvestrant Treatment of Precocious Puberty in Girls with Mccune-albright Syndrome”. International Journal of Pediatric Endocrinology. Springer Science and Business Media LLC. doi:10.1186/1687-9856-2012-26.

clinicaltrials.govStudy

Faslodex in McCune-Albright Syndrome

2006. "Faslodex in McCune-Albright Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00278915.