NCT00910754

Brief Summary

The purpose of this study is to determine the effect of abiraterone acetate plus prednisone on the conduction of electric charges within the heart and to determine the blood levels of abiraterone acetate following administration in patients with metastatic castration-resistant prostate cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2009

Typical duration for phase_1

Geographic Reach
2 countries

8 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

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

May 28, 2009

Last Update Submit

April 11, 2013

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasmsMetastatic castration resistant prostate cancerAbiraterone acetateCB7630

Outcome Measures

Primary Outcomes (1)

  • Mean maximal change in electrocardiogram QTc

    Baseline on Day -1 of Cycle 1 compared with Day 1 of Cycle 1, Cycle 2, Cycle 4 and every third cycle thereafter

Secondary Outcomes (17)

  • Number of participants with change from baseline electrocardiogram QTc >30 msec

    Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug)

  • Number of participants with change from baseline electrocardiogram QTc >60 msec

    Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug)

  • Number of participants affected by an adverse event

    Up to 30 days after the last dose of study medication

  • Number of participants with change in cortrosyn stimulation test

    Baseline and end of study visit (4 weeks after last dose of study drug)

  • Number of participants with change in serum blood levels of testosterone

    Baseline and end of study visit (4 weeks after last dose of study drug)

  • +12 more secondary outcomes

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

Patients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression.

Drug: Abiraterone acetateDrug: Prednisone

Interventions

Abiraterone acetateDRUG

Abiraterone acetate 1000 mg (4 x 250 mg tablets) administered orally once daily.

Abiraterone acetate
PrednisoneDRUG

Prednisone 5 mg tablets administered orally twice daily.

Abiraterone acetate

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Documented metastatic disease
  • Has not received chemotherapy or has no more than one line of cytotoxic chemotherapy or biologic therapy for treatment of castration resistant prostate cancer (CRPC)
  • Documented prostate specific antigen (PSA) progression as assessed by the investigator according to Prostate Cancer Working Group 2 (PCWG2) criteria despite medical or surgical castration, or prostate cancer progression documented by radiographic progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Surgically or medically castrated with testosterone levels of \<50 ng/dL (\<2.0 nM)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1
  • Agrees to protocol-defined use of effective contraception
  • Protocol-specified laboratory parameters

You may not qualify if:

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Abnormal liver function
  • Uncontrolled hypertension
  • Active or symptomatic viral hepatitis or chronic liver disease
  • Known brain metastasis
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline
  • Diagnosis of cardiac arrhythmia
  • Treatment with anti-arrhythmic drugs primarily for cardiac arrhythmia
  • Abnormal electrocardiogram
  • Other malignancy (except non-melanoma skin cancer, that is active or has a ≥ 30% probability of recurrence within 24 months) History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
  • Surgery or local prostatic intervention within 30 days of the first dose
  • Radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1
  • Any acute toxicities due to prior therapy that have not resolved to a NCI CTCAE (version 3.0) grade of \<=1
  • More than one prior cytotoxic chemotherapy or biologic therapy for treatment of CRPC
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

BC Cancer Agency-Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetatePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanes

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2009

Study Completion

May 1, 2012

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

US(6)CA(2)