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: 01 Week Total daily dose: 600 mg/day
Control Intervention1: LYNPARZA (olaparib) tablets: Total Daily dose: 600 mg/day / 1 week
Sponsors
Dr Reddys Laboratories Ltd
Cliantha Research Limited
Eligibility
Inclusion criteria
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. Participant 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 Participant 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 Participant 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 Participant 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: Participant with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. OR Participant 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 Participant 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. Participant with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily for at least 15 days or willing to undergo at least 15 days of stabilization period with Olaparib tablets (2 x 150 mg tablets) 300 mg twice daily. 4. Participant with body mass index (BMI) 18.5-30 kg/m2 (both inclusive). 5. Adequate bone marrow and organ function defined as follows at screening: a. Hemoglobin Greater than or Equal to 9 g/dL or gm percentage with no blood transfusions in the previous 28 days prior to randomization b. Absolute Neutrophil Count (ANC) Greater than or Equal to 1.5 x 109/L or 1500/ mm3 c. White blood cells (WBC) Greater than 3 x 109/L or 3000/ mm3 d. Platelets Greater than or Equal to 100 x 109/L or 100,000/ mm3 e. Total bilirubin Less than or Equal to 1.5 x Upper Limit Normal (ULN) {A} or Less than or Equal to 3 x ULN {A} in the presence of liver metastasis f. AST/ ALT Less than or Equal to 2.5x ULN {A}, if liver metastases then Less than or Equal to 5 x ULN {A} g. Serum creatinine Less than or Equal to 1.5 x ULN {A} {A} Please refer to Appendix III List of Biological Reference Interval for Upper Limits. 6. Calculated serum creatinine clearance Greater than 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl is Equal to (140 Age) x mass (Kilogram weight) Divided by 72 x SCr in (mg/dL) (if female x 85 Percentage).1 7. Eastern Cooperative Oncology Group (ECOG) performance status Less than or Equal to 2 (Appendix-II). 8. Participant with life expectancy
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Participant with a known hypersensitivity to olaparib or any of the excipients of the product and heparin. 2. Participant unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication. 3. Participant 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 (Appendix-I). 5. Participant with any ongoing toxicities except alopecia (CTCAE (Common Terminology Criteria for Adverse Events) Greater than grade 2) caused by previous cancer therapy. 6. Participant with interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 7. Participant with history of or current myelodysplastic syndrome/acute myeloid leukemia. 8. Participant with history/ risk of venous thromboembolic events. 9. Participant with symptomatic uncontrolled brain metastases. Participant can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment. 10. Participant 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 screening or not recovered from any undesirable or harmful effects of any major surgery. 12. Participant 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 randomization. 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 year 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 participant s participation in this study. 21. Any other condition or any clinically significant abnormalities in ECG or laboratory parameters that, in the investigator s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 22. Institutionalized participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of test product Olaparib tablets of Dr. Reddy s Laboratories Ltd., India with Reference Product LYNPARZA (olaparib) tablets 150 mg (2x150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in Adult Participants with Ovarian Cancer or Breast Cancer or Pancreatic Cancer or Prostate Cancer under Fasting Condition.Timepoint: 02 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of the test product in comparison to the reference product in the treated participants. Timepoint: 02 weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed