Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kristoffer Rohrberg
With
Janssen-Cilag Ltd.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent.
Age ≥18 years and male
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
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.
Prostate cancer progression as assessed by the investigator with one of the following:
* PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
* Solid Tumors (RECIST) criteria or bone scans with or without PSA progression.
* Radiographic progression in soft tissue according to Response Evaluation Criteria in
Ongoing androgen deprivation with serum testosterone \<2.0 nM
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Platelet count ≥100,000/μL
Serum albumin ≥30 g/dL
Serum creatinine \<1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
Serum potassium ≥3.5 mmol/L
You may not be if
Received abiraterone or MDV3100 in the past.
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
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 51 µmol/l)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
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.
Active or symptomatic viral hepatitis or chronic liver disease
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 III or IV heart disease or left ventricular ejection fraction (LVEF) of \<50% at baseline.
Known brain metastasis
History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
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.
Use of other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy; diethylstilbestrol; PC-SPES; spironolactone (ie, ALDACTONE, SPIRONOL); and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1 Day 1
Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1
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.
