Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: null- Metastatic castration resistant prostate cancer
Conditions
Interventions
Intervention1: Abiraterone 1000 mg Abiraterone 250 mg: 1000 mg in fasted state
250 mg in fed state
Intervention2: Abiraterone: 250 mg in fed state
Intervention3: Abiraterone: 250 mg in fed state (low
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in age >=18 years 2. Patients with histologically confirmed adenocarcinoma of the prostate 3. Patients with metastatic disease based on a positive bone scan or objective imaging on CT scan 4. mCRPC patients (defined as disease progression despite androgen deprivation therapy i.e., either a luteinizing hormone-releasing hormone agonist or bilateral orchiectomy) who are taking abiraterone 1000 mg for a minimum period of one month.
Exclusion criteria
Exclusion criteria: 1. Patients who are not willing to participate and will not provide signed informed consent 2. Uncontrolled DM, defined as HbA1c >=7.5% 3. Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal at baseline 4. Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal 5. Patients with serum potassium less than 3.5 mEq/dl 6. Patients taking CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org) 7. Patients taking drugs which are substrates of CYP2D6 (dextromethorphan, thioridazine) available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org) 8. Autoimmune disease requiring corticosteroid therapy. Active infection or other medical condition that would contraindicate the use of prednisone/prednisolone (corticosteroid) 9. Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 10. 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 11. Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy 12. Administration of an investigational therapeutic agent within 30 days of screening 13. Prior radiation therapy completed 14. Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g., as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that >1 year has passed since the administration of the last chemotherapy dose 15. Any "currently active" second malignancy. Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next year 16. Active psychiatric illnesses/social situations that would limit compliance with protocol requirements 17. Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated 18. Thyrotoxicosis patients 19. Known brain metastasis 20. History of pituitary or adrenal dysfunction 21. Patients with BMI 18.5 â?? 27.4 kg/m2 22. Patients with lactose intolerance or allergy to milk protein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean maximum plasma concentration (Cmax) Mean area under the plasma concentration-time curve (AUC0-t) Geometric mean ratio of Cmax and AUC0-tTimepoint: 0 hour 1 hour 2 hours 3 hours 4 hours 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactRanjit Kumar Sahoo
AIIMS, New Delhi
Outcome results
None listed