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

Completed · Phase 1

Conditions studied: Prostate Neoplasms

In brief

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.

Key facts

Study ID

NCT00910754

Run by

Janssen Research & Development, LLC

People needed

33

Starts

2009-05-01

Expected to finish

2012-05-01

Last updated by the study team

2013-04-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• Study site — Buffalo, New York, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Study site — Myrtle Beach, South Carolina, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• BC Cancer Agency-Vancouver — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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