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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00094328
First received: October 16, 2004
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Puberty, Precocious
Drug: Bicalutamide
Drug: Anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Growth Rate (cm/Year) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    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).

  • Change in Growth Rate (SD Units) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    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:
  • Change in Bone Maturation Rate [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    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.

  • Normalization of Growth Rate [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    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.

  • Change in Predicted Adult Height (PAH) [ Time Frame: Assessed after 12 months treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: November 2004
Estimated Study Completion Date: August 2017
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bicalutamide with Anastrozole
Bicalutamide in combination with Anastrozole
Drug: Bicalutamide
oral
Other Name: Casodex
Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033

  Eligibility

Ages Eligible for Study:   2 Years to 13 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094328

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States
United States, Pennsylvania
Research Site
Philladelphia, Pennsylvania, United States
United States, South Carolina
Research Site
Greenville, South Carolina, United States
United States, Texas
Research Site
Temple, Texas, United States
United States, Washington
Research Site
Spokane, Washington, United States
Canada, Ontario
Research Site
London, Ontario, Canada
France
Research Site
Montpellier Cedex, France
India
Research Site
Chennai, India
Research Site
New Dehli, India
Russian Federation
Research Site
Moscow, Russian Federation
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Yuri E Rukazenkov, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00094328     History of Changes
Other Study ID Numbers: D6873C00047, BATT
Study First Received: October 16, 2004
Results First Received: May 19, 2009
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Testotoxicosis
Familial Male-limited Precocious Puberty (FMPP)

Additional relevant MeSH terms:
Puberty, Precocious
Endocrine System Diseases
Gonadal Disorders
Anastrozole
Bicalutamide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014