Health Condition 1: null- METASTATIC PROSTATE CANCER
Conditions
Interventions
Intervention1: Nilutamide Tablet 150 mg: Nilutamide Tablet 150 mg Manufactured by Stason Pharmaceuticals Inc. USA
Control Intervention1: Nilandron (Nilutamide) tablet 150 mg: Nilandron (Nilutamide) ta
Sponsors
Stason Pharmaceutical Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to participate by providing written informed consent. 2. Male between 30 to 70 years of age with a histopathologically confirmed metastatic prostate cancer consistent with stage D2 (Stage IV [subtype D2] metastatic prostate cancer). 3. Body mass index of 18â??25 kg/m2 (both inclusive). 4. Patients who completed the active run-in period (30 days at 300mg followed by 150 mg once a day as their individual therapy for at least 15 days prior to randomization). 5. Performance status with 0 or 1 as per Eastern Cooperative Oncology Group (ECOG) scale. 6. Life expectancy must be >= 6 months. 7. Laboratory values must be as follows: ï?? White blood cell count: >= 3,000/mm3, ï?? Absolute granulocyte count: >= 1,500/mm3 ï?? Platelets: >= 100,000/mm3 ï?? Hemoglobin: >= 8g/dL ï?? Serum creatinine: ï?? Alkaline Phosphatase ï?? AST: ï?? ALT: ï?? Serum calcium: ï?? Total bilirubin: 8. Patient must be willing to provide written informed consent and agree to - use effective contraception while on treatment and for three months after completion of therapy.
Exclusion criteria
Exclusion criteria: 1. Patients with any pre-planned inpatient hospitalizations for a procedure or elective surgery that would occur during participation in the study. 2. Patients with a history of severe hypersensitivity reaction to nilutamide or any component of this preparation. 3. Patient has received any other investigational agent within 90 days of first day of study drug dosing. 4. Patient has another severe and/or life-threatening medical disease. 5. Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure. 6. Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation. 7. Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent. 8. Patients with known evidence of brain metastases or carcinomatous meningitis. 9. Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair. 10. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. 11. Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection. 12. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. 13. Patients with current peripheral neuropathy of any etiology that is greater than Grade I. 14. Patient with a history of severe hepatic impairment and severe respiratory insufficiency. 15. Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects. 16. Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects. 17. Previous history or evidence of drug abuse in past 10 years 18. Positive serological tests for HIV, Hepatitis B &/or C. 19. Patient who are considered for any reason by the investigator to be inappropriate for study participation. 20. Patient who are not expected to survive for the duration of the study. 21. Refuse to abstain from food for at least 10 h before dosing and for at least 4 h after dose in each period. 22. Refuse to abstain from fluid for at least 1 h before and 1 h after dosing. 23. Patients with documented anti androgen withdrawal syndrome with nilutamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate pharmacokinetic bioequivalence of Nilutamide tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients.Timepoint: Two 28 days assessment periods i.e. on 56th day assessment will be done. tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Nilutamide tabletsTimepoint: During the study period | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah MD
Syngene International Limited
Outcome results
None listed