prostate cancer
Conditions
Interventions
The study will consist of a 28-day screening phase, a treatment phase and a
follow-up phase.
During the screening phase the eligibility is determined.
At the start of the treatment phase all subjec
Sponsors
Johnson & Johnson Pharmaceutical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men >= 18 years of age or older (inclusive).;2. Eastern Cooperative Oncology Group (ECOG) performance status =9.0 g/dL, independent of transfusion and/or growth factor support; ANC count >=1,500 cells/mm3 independent of growth factor support within the prior 3 months; Platelet count >=75,000/µL independent of transfusion and/or growth factor;support within the prior 3 months; Serum albumin >=3.0 g/dL;Serum creatinine <1.5 × upper limit of normal (ULN) or calculated creatinine;clearance >= 50 mL/min/1.73m2; Serum potassium >= 3.5 mmol/L; Total bilirubin < 1.5 × ULN (Subjects with Gilbert*s Syndrome may be enrolled;if the total bilirubin is < 3 mg/dL with predominance of indirect bilirubin); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating;in the study.;1. Known brain metastases;2. Pathological finding consistent with small cell carcinoma of the prostate;3. Administration of an investigational agent within 4 weeks of Cycle 1 Day 1;4. Chemotherapy, or immunotherapy for the treatment of PC within 4 weeks of Cycle 1 day 1;5. Therapies that must be discontinued or substituted at least 4 weeks prior to Cycle 1 Day 1 include the following: Medications known to lower the seizure threshold (see Section 8.3); Herbal and non-herbal products that may decrease PSA levels (ie, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John*s;wort, etc. (see Section 8.3); Potent inhibitors of CYP3A4 (see Section 9.3);6. Subjects currently treated with spironolactone;7. Subject has known allergies, hypersensitivity, or intolerance to prednisone or the excipients of prednisone, AA or JNJ-56021927 (refer to Investigator's Brochures for AA and JNJ-56021927 and package insert for Prednisone) ;8. Known hypersensitivity to Vitamin E;9. History of seizures or presence of a condition that may pre-dispose to seizure (eg, prior;stroke within 1 year prior to Cycle 1 Day 1, brain arteriovenous malformation,Schwannoma, meningioma, or other benign CNS or meningeal disease, which may require treatment with surgery or radiation therapy);10. Any prior malignancy (other than adequately treated basal cell or squamous cell skin;cancer, superficial bladder cancer, or any other cancer in situ currently in complete;remission) within 3 years prior to Cycle 1 Day 1;11. History or evidence for any of the following: severe or unstable angina or myocardial;infarction within 12 months prior to Cycle 1 Day 1, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), clinically significant;ventricular arrhythmias or New York Heart Association (NYHA) Class III to IV heart disease;12. Presence of uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 100;mmHg). Subjects with a history of hypertension are allowed, provided that BP is;controlled to within these limits by anti-hypertensive treatment;13. Presence of gastrointestinal disorder affecting absorption;14. History or evidence for adrenal insufficiency or hyperaldosteronism;15. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or other;medical condition that would make prednisone (corticosteroid) use contraindicated;16. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg;prednisone daily within 4 weeks prior to Cycle 1 Day 1 and up to Cycle 2 Day 8;17. Subject has any condition for which, in the opinion of the investigator, participation;would not be in the best interest of the subject (eg, compromise the well-being) or that;could prevent, limit, or confound the protocol-specified assessments;18. Subject is an employee of the investigator or study site, with direct involvement in the;proposed study or other studies under the direction of that investigator or study site, as;well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the effect of JNJ-56021927 on steady state abiraterone pharmacokinetics in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) during combination treatment of JNJ-56021927 with abiraterone acetate plus prednisone. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: * To characterize the safety profile of JNJ-56021927 in combination with AAP * To evaluate clinical efficacy of JNJ-56021927 in combination with AAP * To characterize the pharmacokinetic (PK) profile of JNJ-56021927 when dosed in combination with AAP | — |
Countries
Netherlands
Outcome results
None listed