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. - BATT (Biclutamide anatrozole treatment for testotoxicosis)

• Register: EUCTR
• Last refreshed on: 14 August 2012
• Main ID: EUCTR2004-000384-10-FR
• Date of registration: 22/02/2006
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public 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. - BATT (Biclutamide anatrozole treatment for testotoxicosis)
• Scientific 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. - BATT (Biclutamide anatrozole treatment for testotoxicosis)
• Date of first enrolment: 19/12/2006
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000384-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

France, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Provision of written informed consent of parent/ legal guardian and subject assent
(as needed by local requirements)
2. Male aged 2 years and over
3. Diagnosis of testotoxicosis based on the following:
-clinical features of:
i) progressive sexual precocity documented by Tanner staging and evidence of
symmetrical testicular enlargement
ii) 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:
i) 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'.
ii) normal levels of 17-hydroxyprogesterone (17-OHP)
iii) normal levels of dehydroepiandrosterone sulphate (DHEAS)
4. Naïve to anti androgen receptor therapy (Note: Ketoconazole and spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)
5. A documented reliable height measurement taken at least 6 months prior to study
enrolment. 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 at leats 6 months prior to study entry)
6. 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

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Evidence of central precocious puberty as demonstrated by GnRH stimulation test
2. Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5
times the upper limit of normal for age
3. Serum concentration of creatinine greater than 1.5 times the upper limit of normal
for age
4. 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
5. Known hypersensitivity to any of the study medications
6. Participation in a clinical study at the time of enrolment



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

testotoxicosis (familial male-limited gonadotropin-independent precocious puberty)
MedDRA version: 7.1 Level: PT Classification code 10063654

Intervention(s)

Product Name: Anastrozole orodispersible tablet
Product Code: ZD1033
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Anastrozole
CAS Number: 120511-73-1
Current Sponsor code: ZD1033
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Anastrozole
CAS Number: 120511-73-1
Current Sponsor code: ZD1033
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: Biclutamide orodispersible tablet
Product Code: ZD7054
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Biclutamide
CAS Number: 90357-06-5
Current Sponsor code: ZD7054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
INN or Proposed INN: Biclutamide
CAS Number: 90357-06-5
Current Sponsor code: ZD7054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): Change in growth rate after 12 months of treatment relative to the growth rate
during the 6 months or more pre-study period

Secondary Objective: 1. To investigate efficacy of bicalutamide when used in combination with
anastrozole in terms of reduction in growth rate after 6 months treatment by
assessment of change in growth rate after 6 months of treatment relative to the
growth rate during the 6 months or more pre-study period.
2. To investigate efficacy of bicalutamide when used in combination with
anastrozole in terms of reduction in bone age maturation rate after 6 & 12
months treatment by assessment of change in rate of bone age maturation after 6
& 12 months of treatment relative to rate of bone age maturation during the 6 months or more pre-study period for patients with retrospective bone age.
3. To investigate efficacy of bicalutamide when used in combination with
anastrozole in terms of normalization of growth rate by number and percentage of
subjects who achieve and/or maintain growth rates between the 5 th and the 95 th
percentile for chronological age at 3, 6, 9 and 12 months of treatment.
PLUS OTHERS

Main Objective: The primary objective of this study is to assess the efficacy of bicalutamide when used in combination with anastrozole in terms of a reduction in growth rate after 12 months treatment of precocious puberty in boys with testotoxicosis by assessment of change in growth rate after 12 months of treatment relative to the growth rate during the 6 months or more pre-study period.

Secondary ID(s)

2004-000384-10-GB

D6873C00047