Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Olaparib Tablets 150 mg: Dose: Olaparib tablets 150 mg (two tablets of 150 mg)
From Day 01 to Day 05 in Period-I, Day 06 to Day 10 in Period-II, Day 11 to Day 15 in Period-III and Day
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive). 2. Participant with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Note: Participants must have confirmation of germline BRCA mutation before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Note: Participant with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Note: Participants must have confirmation of BRCA mutation (identified by either germline or tumour testing) before olaparib treatment is initiated. OR Participant with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. Note: Platinum-sensitive relapse is defined as disease progression occurring at least 6 months following completion of platinum chemotherapy. OR Participant with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Note: Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. Note: BRCA or ATM mutations must be confirmed before olaparib treatment is initiated. OR In combination with abiraterone and prednisone or prednisolone for the treatment of adult participants with deleterious or suspected deleterious germline and/or somatic BRCA mutated mCRPC in whom chemotherapy is not clinically indicated Note: BRCA mutations must be confirmed before olaparib treatment is initiated. 3. Participant with body mass index (BMI) 18.5 to 30.0 kg/m2 (both inclusive). 4. Participant with established dosing regimen who are already receiving a stable dose of olaparib tablets (2x150 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 (2x150 mg tablets) 300 mg twice daily. 5. Participant with life expectancy greater than or equals to 3 months. 6. Acceptable hematology status: a. Hemoglobin greater than or equals to 10 g/dL with no blood transfusions in the previous 28 days prior to randomization. b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/µL. c. Platelet count greater than or equals to 1,00,000 cells/µL. 7. Acceptable liver function: a. Alanine aminotransferase (ALT) less than or equals to 2.5 x upper li
Exclusion criteria
Exclusion criteria: 1. Participant with a known hypersensitivity to olaparib or any of the excipients of the product. 2. Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), or radiotherapy within 4 weeks prior to stabilization. 3. Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization. 4. Participant with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) greater than or equals to grade 2), with the exception of alopecia, caused by previous cancer therapy. 5. Participant with interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 6. Participant with known myelodysplastic syndrome/acute myeloid leukemia. 7. Participant with known history/ risk of venous thromboembolic events. 8. 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. Participant with cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. 9. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery. 10. History of other malignancies in the last 5 years (Potential participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible). 11. Current or anticipated use of any prohibited medications during study participation. 12. Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducers. 13. Participant with serum positivity for Hepatitis B, C or HIV. 14. 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. 15. 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. Johns wort) within 48 hours prior to randomization. 16. 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. 17. Use of grapefruit and grapefruit containing products within 07 days prior to randomization. 18. Participation in any investigational drug study within 30 days prior to screening. 19. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 20. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 21. Participant who is unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication. 22. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the participants participation in this study. 23. Any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmaxss, Cminss and AUC0-taussTimepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Cpdss and Tmaxss Safety endpoints: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE).Timepoint: 3 Weeks | — |
Countries
India
Contacts
Public ContactMr Mohit Vyas
Cliantha Research Limited
Outcome results
None listed