EUCTR2010-021425-13-ITActive, not recruitingNot Applicable
An Open-Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy - ND
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 5,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •Each subject must meet the following criteria to be enrolled in this study. 1 Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 2 Written Authorization for Use and Release of Health and Research Study Information (United States [U.S.] sites only) or Data Protection Consent (European sites only) has been obtained. 3 Subjects at sites which are participating in the collection of QoL/MRU data will be asked to provide written informed consent for the collection of these personal data. 4 Age =18 years and male 5 Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology 6 Received at least one but not more than two cytotoxic chemotherapy regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel. If a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen. 7 Prostate cancer progression as assessed by the investigator with one of the following: – PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria – Radiographic progression in soft tissue according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria or bone scans with or without PSA progression. 8 Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM) 9 Eastern Cooperative Oncology Group (ECOG) performance status of =2 10 Hemoglobin =9.0 g/dL independent of transfusion 11 Platelet count =100,000/µL 12 Serum albumin =3.0 g/dL 13 Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance = 60 mL/min 14 Serum potassium =3.5 mmol/L 15 Able to swallow the study drug whole as a tablet
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from the study: 1 Eligible for another study of abiraterone acetate that is open to enrollment. Medical monitor review will be required to allow enrollment on this study if a subject is eligible for another abiraterone acetate open study 2 Received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302. 3 Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection 4 Abnormal liver functions consisting of any of the following: – Serum bilirubin =1.5 x ULN (except for subjects with documented Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL) – Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x ULN 5 Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. 6 Active or symptomatic viral hepatitis or chronic liver disease 7 History of pituitary or adrenal dysfunction 8 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 III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline 9 Known brain metastasis 10 History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug 11 Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of =1. Chemotherapy induced alopecia and Grade 2 peripheral neuropathy is allowed.3 12 Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1 13 Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Day 1 14 Condition or situation which, in the investigator’s opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with subject’s participation in the study 15 Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and Sponsor during the study and for 13 weeks after last study drug administration.
Investigators
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