Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C56- Malignant neoplasm of ovary Health Condition 3: C25- Malignant neoplasm of pancreas Health Condition 4: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Olaparib Tablets 150 mg: Dosage: 150mg Frequency: 2x150mg tablets twice-daily Route of administration: Oral Duration: 14 days
Control Intervention1: Lynparza® (Olaparib) Tablets 150 mg:
Sponsors
Dr. Reddy’s Laboratories Ltd
Ms Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female between 18-75 years of age (both inclusive) who are willing to provide informed consent to participate in the study. 2. Patient with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. OR Patient with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. OR Patient with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. OR Patient with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Note: Patient with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. OR Patient with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. OR Patient with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. 3. Patient with an established dosing regimen who already are receiving a stable dose of olaparib or if naïve to olaparib, are willing to undergo at least 15 days of stabilization period with olaparib tablets, 150 mg (Dose: 600 mg/day). 4. Patient with body mass index (BMI) 18-30 kg/m2 (both inclusive). 5.Adequate bone marrow and organ function a. Hemoglobin = 9 g/dL or gm% with no blood transfusions in the previous 28 days prior to randomization b. Absolute Neutrophil Count c. White blood cells d. Platelets e. Total bilirubin = 1.5 x Upper Limit Normal (ULN) or = 3 x ULN in the presence of liver metastasis f. AST/ ALT = 2.5 x ULN, if liver metastases then = 5 x ULN g. Serum creatinine = 1.5 x ULN 6. Calculated serum creatinine clearance 7. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 8. Patient with life expectancy = 14 weeks. 9. Male patient if sexually active with a female of child-bearing potential must agree to use barrier method of contraception throughout the study period and for at least 3 months after last dose of study drug. 10. Female patient with postmenopausal status or female patient of child-bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. Postmenopausal is defined by any one of the following: a. Postmenopausal with spontaneous amenorrhea for at least one year, or. b. 6 months to 12 months of spontaneous amenorrhea with serum c. Bilateral oophorectomy with or withou
Exclusion criteria
Exclusion criteria: 1. Patient with a known hypersensitivity to olaparib or any of the excipients of the product. 2. Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication. 3. Patient receiving any systemic chemotherapy, radiotherapy within 4 weeks before randomization. 4. Concomitant use of known strong or moderate CYP3A4 (Cytochrome P4503A4) inhibitors or inducer within 14 days before start of study medication. 5. Patient with any ongoing toxicities except alopecia 6. Patient with deleterious or suspected deleterious gBRCA mutation and advanced ovarian cancer who has been treated with three or more prior lines of chemotherapy. 7. Patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 8. Patient with history of or current myelodysplastic syndrome/acute myeloid leukemia. 9. Patient with history/ risk of venous thromboembolic events. 10. 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 spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. 11. Major surgery within 2 months of study starting and patient must have recovered from any undesirable or harmful effects of any major surgery. 12. Patient with serum positivity for Hepatitis B, C, or HIV at screening visit. 13. Consumption of any grapefruit, star fruit, grape fruit juice, seville oranges, and seville orange juice and its products within 07 days prior to first dosing of Period-I. 14. Ingestion of any alcoholic food (e.g. plum pudding, cake, chocolate containing alcohol) or beverage containing alcohol or utilize recreational drugs, caffeine or xanthine containing food or beverage within the 48 hours prior to randomization. 15. History of drug dependence, history of alcoholism [more than 2 drinks per day, 1 drink is defined as 360 mL of beer, 240 mL of malt liquor, 150 mL of wine and 45 mL of distilled spirits (gin, rum, vodka, whiskey, etc.)] in the past 1 years prior to screening. 16. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days. 17. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 18. Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system, with the exception of the cancer under treatment. 19. Participation in any investigational drug study within 30 days prior to screening. 20. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patient’s participation in this study. 21. Any other condition that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint(s): Cmaxss and AUC0-tauss Secondary Endpoint(s): Cminss, Tmaxss, Cavss, degree of Fluctuation, and Swing Timepoint: 2 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: 3 Week | — |
Countries
India
Contacts
Public ContactMr Rikin Patel
Cliantha Research Ltd.,
Outcome results
None listed