Health Condition 1: D498- Neoplasm of unspecified behavior of other specified sites
Conditions
Interventions
Intervention1: Olaparib Tablets, 150 mg: Dosage: 150mg
Frequency: 2x150mg tablets twice-daily
Route of administration: Oral
Duration: 06 days
Control Intervention1: LYNPARZA® 150mg Tablets: Dosage: 1
Sponsors
AET Laboratories Private Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant, non-lactating female having aged 18-65 years (both inclusive). 2. Patient with body mass index (BMI) 18.5 to 30 kg/m2. 3. Patient with advanced (FIGO stages III and IV) deleterious or suspected deleterious germline and/or somatic BRCA- mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. OR Patient with maintenance treatment with platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first line platinum-based chemotherapy. OR Monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patient with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. OR Patient with deleterious or suspected deleterious gBRCAm, HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo) adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. OR Patient with monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. OR In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. 4. Patient with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily or willing to undergo at least 15 days of stabilization period with olaparib tablets, 150 mg. NOTE: For the patients who will enter into the stabilization period, the criteria will be evaluated during screening part II. 5. Patient having body weight = 45 Kg. 6. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 7. Patient with life expectancy greater than 90 days. 8. Acceptable Haematology status: a. Haemoglobin Greater than or equal to 9 g per dL. b. Absolute neutrophil count (ANC) Greater than or equal to 1500 cells per microliter c. Platelet count Greater than or equal to 1, 00,000 cells per microliter 9. Calculated serum creatinine clearance =50 mL/min (using Cockcroft-Gault formula)2 which is as follows: Formula of creatinine clearance: CrCl equals to (140 – Age) x mass (kilogram weight) divided by 72 x SCr in (mg/dL) (if female then x 85 percentage). 10. No history of addiction to any recreational drug or drug dependence or alcohol addiction within 1 year prior to screening. 11. Acceptable liver function: a. Alanine aminotransferase Less than or equal to 2.0 x upper limit of normal (ULN) b. Aspartate aminotransferase (AST) Less than or equal to 2.0 x upper limit of normal (ULN) c. Total bilirubin Less than or equal to
Exclusion criteria
Exclusion criteria: Patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. Patient with a known hypersensitivity to olaparib or any of the excipients of the product. 2. Patient who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomisation. 3. Patient who are unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication. 4. Patient receiving any systemic chemotherapy, radiotherapy within 4 weeks prior to randomisation. 5. Current or anticipated use of any prohibited medications during study participation. 6. Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducer. 7. Patient with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) = grade 2), with the exception of alopecia, caused by previous cancer therapy. 8. QTc (Heart Rate Corrected QT interval) greater than 450 msec (male) or greater than 470 msec (female) or family history of long QT syndrome. QT interval will be calculated with Bazett’s Formula. 9. Patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 10. Patient with myelodysplastic syndrome/acute myeloid leukemia. 11. Patient with history/ risk of venous thromboembolic events. 12. Patient with symptomatic uncontrolled brain metastases. Patient can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment. Patient with cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. 13. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery. 14. History of other malignancies in the last 5 years (Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible). 15. Patient with known serum positivity for Hepatitis B, C or HIV. 16. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, dietary items that have effect on P450 enzymes (e.g., pomegranate, star fruit, seville oranges) and PGP (P-Glycoprotein) efflux pump (e.g., St. John’s wort) within 48 hours prior to the first dose of study medication. 17. Use of grapefruit and grapefruit containing products within 07 days prior to randomisation. 18. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days. 19. Patient who has received an investigational drug or participation in drug research study within 90 days prior to randomisation. 20. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 21. Any significant disease or condition which might compromise the haemopoietin, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system. 22. Institutionalized patient. 23. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patient’s participation in this study. 24. Any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of OLAPARIB TABLETS, 150 mg (2 x 150 mg Tablets) with LYNPARZA® 150 mg Olaparib Tablets (2 x 150 mg Tablets) of AstraZeneca AB, Sweden under fed condition.Timepoint: 2 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of patients.Timepoint: 2 Weeks | — |
Countries
India
Contacts
Public ContactMr Maulik Patel
Cliantha Research limited
Outcome results
None listed