Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] (BATT)

Study Description

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Brief Summary:

The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

Condition or disease	Intervention/treatment	Phase
Puberty, Precocious	Drug: Bicalutamide; Drug: Anastrozole	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis
Actual Study Start Date :	November 22, 2004
Actual Primary Completion Date :	May 22, 2008
Actual Study Completion Date :	December 6, 2017

Arms and Interventions

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Arm	Intervention/treatment
Bicalutamide with Anastrozole; Bicalutamide in combination with Anastrozole	Drug: Bicalutamide; oral; Other Name: Casodex Drug: Anastrozole; oral; Other Names: Arimidex; ZD1033

Outcome Measures

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Primary Outcome Measures :

1. Change in Growth Rate (cm/Year) [ Time Frame: Assessed after 12 months treatment ]
   Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
2. Change in Growth Rate (SD Units) [ Time Frame: Assessed after 12 months treatment ]
   Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).

Secondary Outcome Measures :

1. Change in Bone Maturation Rate [ Time Frame: Assessed after 12 months treatment ]
   Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 months and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation was calculated from this rate and that calculated at 12 months.
2. Normalization of Growth Rate [ Time Frame: Assessed after 12 months treatment ]
   The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.
3. Change in Predicted Adult Height (PAH) [ Time Frame: Assessed after 12 months treatment ]
   Radiographs will be used to assess the bone age, the PAH is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH will be calculated by subtracting the PAH at baseline from the PAH at 12 months.

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 13 Years (Child)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements)
• Male aged 2 years and over
• Diagnosis of testotoxicosis based on the following:
• Clinical features of Progressive sexual precocity documented by Tanner staging and evidence of symmetrical testicular enlargement
• Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age)
• Pubertal levels of serum testosterone
• Prepubertal levels of serum gonadotropins
• Lack of an increase in serum gonadotropin levels following GnRH stimulation
• Other pathology excluded by:
• Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below the LOQ will be reported as "<10 IU/L" which in the clinical setting equate to 'undetectable'.
• Normal levels of 17-hydroxyprogesterone (17-OHP)
• Normal levels of dehydroepiandrosterone sulphate (DHEAS)
• Naive to anti androgen receptor therapy:

(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)

• A documented reliable height measurement taken > 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.

(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and > 6 months prior to study entry)

• Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis.

Exclusion Criteria:

• Evidence of central precocious puberty as demonstrated by GnRH stimulation test
• Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age
• Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age
• Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance
• Known hypersensitivity to any of the study medications
• Participation in a clinical study at the time of enrollment

Contacts and Locations

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Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States, 35233
United States, Florida
Research Site
Jacksonville, Florida, United States, 32207
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55416
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29615
United States, Texas
Research Site
Temple, Texas, United States, 76508
United States, Washington
Research Site
Spokane, Washington, United States, 99204
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 4G5
France
Research Site
Montpellier Cedex, France, 34295
India
Research Site
Chennai, India, 600020
Research Site
New Dehli, India, 110029
Russian Federation
Research Site
Moscow, Russian Federation, 117036
United Kingdom
Research Site
London, United Kingdom, WC1N 3JH

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Yuri E Rukazenkov, MD	AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US 

CSR-D6873C00047.pdf 

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00094328 History of Changes
Other Study ID Numbers:	D6873C00047; BATT
First Posted:	October 18, 2004
Results First Posted:	July 9, 2009
Last Update Posted:	March 14, 2018
Last Verified:	January 2018

Keywords provided by AstraZeneca:

Testotoxicosis; Familial Male-limited Precocious Puberty (FMPP)

Additional relevant MeSH terms:

Puberty, Precocious; Gonadal Disorders; Endocrine System Diseases; Anastrozole; Bicalutamide; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Aromatase Inhibitors	Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Androgen Antagonists