Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Olaparib Tablets 150 mg: Olaparib Tablets 150 mg (two tablets) will be administered in the morning and evening, at an interval of at least 12 hours ( 60 minutes) between the doses, i.e
Sponsors
Win Medica S.A.
Cliantha research limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant, non-lactating female between 18-65 years of age(both inclusive). 2. Participant with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/ or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who is in response (complete or partial) following completion of first-line platinum-based chemotherapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who is in response (complete or partial) to platinum-based chemotherapy. OR Monotherapy or in combination with endocrine therapy for the adjuvant treatment of participant with germline BRCA1/2-mutations who has HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with germline BRCA1/2-mutations, who has HER2 negative locally advanced or metastatic breast cancer. Participant should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless participants were not suitable for these treatments. Participants with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with germline BRCA1/2-mutations who has metastatic adenocarcinoma of the pancreas and has not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who has progressed following prior therapy that included a new hormonal agent. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. 3. Participant with body mass index (BMI) 18.5-30.0 kg/m2 (both inclusive). 4. 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. 5. Participant with life expectancy greater than 90 days. 6. Acceptable hematology status at screening & prior to randomization: a. Hemoglobin greater than or equals to 9 g/dL. b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/microliter. c. Platelet count greater than or equals to 1,00,000 cells/microliter. d. WBC count greater than 3000/mm3 7. Acceptable liver function at screening & prior to randomization: a. Alanine aminotransferase (ALT) less than or equals to 2.5 X Upper Limit Normal (ULN) (less than or equals to 5 X ULN for liver metastasis). b. Aspartate aminotransferase (AST) less than or equals to 2.5 X ULN (less than or equa
Exclusion criteria
Exclusion criteria: Participant will not be eligible for inclusion in this study if any of the following criteria apply: 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), 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 known interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 6. Participant with known myelodysplastic syndrome/acute myeloid leukemia. 7. Participant with 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 spinal 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 strong or moderate CYP3A (Cytochrome P450 3A) inhibitors or inducer within 14 days before start of study medication/randomization. 13. Participant with serum positivity for Hepatitis B, C or HIV. 14. Participants with severe hepatic impairment (Child-Pugh classification C) 15. 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. 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) & PGP (P-Glycoprotein) efflux pump (e.g., St. John s wort) within 48 hours prior to randomization. 17. 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. 18. Participant positive on alcohol urine analysis test at the time of baseline/randomization visit. 19. Use of grapefruit and grapefruit containing products within 07 days prior to randomization. 20. Participation in any investigational drug study within 60 days prior to screening. 21. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint(s): CmaxSS and AUC (0-tauSS)Timepoint: 2 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Endpoint(s): Ctauss, CminSS, CavSS, degree of fluctuation % [(CmaxSS-CminSS)/CavSS], swing [(CmaxSS-CminSS)/CminSS], and Tmax. Safety endpoints: Incidence of Treatment-Emergent Adverse Events (TEAEs) and serious adverse events (SAE). Timepoint: 2 Weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Ltd
Outcome results
None listed