A QT/QTc and Multi-Dose Pharmacokinetic Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

NCT00887198

Prostate Cancer

COMPLETED PHASE3

A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

NCT01695135

Prostate Neoplasms

COMPLETED PHASE3

An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

NCT00485303

Prostatic Neoplasms Prostate Cancer

COMPLETED PHASE2

A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01834209

Prostate Neoplasms

NO_LONGER_AVAILABLE

Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

NCT01591122

Prostate Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label (identity of assigned study drugs will be known) study to evaluate the effects of abiraterone acetate plus prednisone on the conduction of electric charges within the heart in male patients diagnosed with metastatic castration-resistant prostate cancer (a progressive form of prostate cancer that spreads to other parts of the body). At various time points outline in the protocol from Day -1 of Cycle 1 up to Day 2 of Cycle 2, patients will have electrocardiograms extracted from a 24 hour holter-monitor to evaluate the electrical activity of their heart. Efficacy will be assessed according to Prostate Cancer Working Group 2 and modified Response Evaluation Criteria In Solid Tumors criteria. Serial blood samples for pharmacokinetic analysis (how the drug concentrations change over time) will be collected and safety will be monitored throughout the study. Patients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression and will be followed up for up to 60 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abiraterone acetate

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

Group Type EXPERIMENTAL

Abiraterone acetate

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

Prednisone 5 mg tablets administered orally twice daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abiraterone acetate

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

Intervention Type DRUG

Prednisone

Prednisone 5 mg tablets administered orally twice daily.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Prior chemotherapy with mitoxantrone or other anthracyclines (ie, doxorubicin, daunomycin, epirubicin and idarubicin)
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
* Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1 Day 1
* Prior bicalutamide (Casodex), nilutamide (Nilandron, Anandron) within 6 weeks of Cycle 1 Day 1
* Previous abiraterone acetate or other investigational CYP17 inhibitor (eg, TAK-700)
* Previous investigational antiandrogens (eg, MDV3100, BMS-641988)
* Patients receiving anti-coagulant therapy
* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No