Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C570- Malignant neoplasm of fallopian tube Health Condition 3: C56- Malignant neoplasm of ovary Health Condition 4: C482- Malignant neoplasm of peritoneum,unspecified
Conditions
Interventions
Intervention1: Olaparib Tablets 150 mg Manufactured by Zhejiang Kisun Pharmaceutical Co., Ltd.): Dose: Two tablets 150 mg x 2 will be administered twice daily (total daily dose 600 mg) from Day 01 to
Sponsors
STADA Arzneimittel AG
Cliantha Research 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 body mass index (BMI) 18.0-30.0 kg/m2 (both inclusive). 3. Any one of the following histopathological confirmed cancers: a. 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. OR b. 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 c. Participant with germline BRCA1/2- mutations who has HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. OR d. 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. 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 6 months. 6. Acceptable hematology status: a. Hemoglobin greater than or equals to 9 g/dL. b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/microL. c. Platelet count greater than or equals to 1,00,000 cells/microL. 7. Acceptable liver function: a. Alanine aminotransferase (ALT) less than or equals to 2x Upper Limit Normal (ULN) (less than or equals to 5 x ULN for liver metastasis). b. Aspartate aminotransferase (AST) less than or equals to 2x ULN (less than or equals to 5 x ULN for liver metastasis) c. Total bilirubin less than or equals to 1.5 x ULN (less than or equals to 3 x ULN for liver metastasis). d. Alkaline phosphatase less than or equals to 2x ULN. 8. Calculated serum creatinine clearance greater than or equals to 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance CrCl equals to (140 - Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if female x 85 Percent. 9. Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2 (Appendix II). 10. Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to screening). 11. Male participant if sexually active with a female of childbearing potential must agree to use barrier method of contraception throughout the study period and for at least 6 months after last dose of study drug. 12. Female with postmenopausal status or female of childbearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at l
Exclusion criteria
Exclusion criteria: 1. Participant with a known hypersensitivity to olaparib or any of the excipients of the product and heparin. 2. Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), radiotherapy within 4 weeks prior to study treatment 3. Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy. 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 potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducer within 14 days before start of study medication/randomization (Appendix I). 13. Participant with serum positivity for Hepatitis B, C or HIV. 14. Any significant disease or condition which might compromise the haemopoietic, 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 (i.e. Tetrahydrocannabinol, amphetamine, barbiturates, cocaine, benzodiazepines, and morphine) within 48 hours prior to randomization. 16. Participants should not consume any products containing poppy seeds within 3 days prior to the first dose of study medication. 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. Use of grapefruit and grapefruit containing products within 14 days prior to randomization. 19. Participation in any investigational drug study within 30 days prior to screening. 20. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 21. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 22. Participant who are unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication. 23. Any food allergy, intolerance,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: CmaxSS and AUCtauSS Secondary Outcome: CtauSS, TmaxSS, CminSS, CavSS and % fluctuation Timepoint: Up to 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: Up to 6 weeks | — |
Countries
India
Contacts
Public ContactMr Rikin Patel
Cliantha Research Limited
Outcome results
None listed