Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C56- Malignant neoplasm of ovary Health Condition 3: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Olaparib Tablets 150 mg of Biocon Pharma Limited India: Dose : Two tablets 150 mg X 2 will be administered twice daily total dose 600 mg per day from Day 01 to Day 08 in period I and D
Sponsors
Biocon Pharma Limited
Cliantha Corporate
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive). 2. Patient with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who is 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 is 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 has been treated with neoadjuvant or adjuvant chemotherapy. OR Patient with deleterious or suspected deleterious gBRCAm, HER2- negative metastatic breast cancer, who has been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Note: Patient with hormone receptor (HR)-positive breast cancer should has been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. OR Patient with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who has progressed following prior treatment with enzalutamide or abiraterone. OR Combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). 3. Patient with body mass index (BMI) 18.0-30.0 kg/m2 (both inclusive). 4. Patient with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 x150 mg tablets) 300 mg twice daily or willing to undergo at least 15 days of stabilization period with olaparib tablets, 150 mg. 5. Patient with life expectancy less than 90 days. 6. Acceptable hematology status: a. Hemoglobin less than or equal to 9 g/dL. b. Absolute neutrophil count (ANC) less than or equal to 1500 cells/?L. c. Platelet count less than or equal to 1,00,000 cells/?L. 7. Acceptable liver function: a. Alanine aminotransferase (ALT) greater than or equal to 2X Upper Limit Normal (ULN) (greater than or equal to 5 X ULN for liver metastasis). b. Aspartate aminotransferase (AST) greater than or equal 2X ULN (greater than or equal 5 X ULN for liver metastasis). c. Total bilirubin greater than or equal 1.5 x ULN. d. Alkaline phosphatase greater than or equal 2X ULN. 8. Calculated serum creatinine clearance less than or equal to 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl equal to (140 ?Age) x mass (Kilogram weight) per 72 x S.Cr in (mg/dl), if female x 85 percent 9. Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal 2. 10. 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 6 months after last dose of study drug. 11. Female with postmenopausal status or female of child bearing potential with negative pregnancy test must agree to practice an accep
Exclusion criteria
Exclusion criteria: 1. Patient with a known hypersensitivity to olaparib or any of the excipients of the product. 2. Patient who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to enrollment on study. 3. Patient who are unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication. 4. Patient receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), radiotherapy within 4 weeks prior to study treatment. 5. Patient with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) less than or equal to grade 2), with the exception of alopecia, caused by previous cancer therapy. 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. QTc (Heart Rate Corrected QT interval) less than 450 msec (male) or less than 470 msec (female) or family history of long QT syndrome. QT interval will be calculated with Bazett?s Formula. 8. Female patient who is breastfeeding and lactating. 9. Current or anticipated use of any prohibited medications during study participation. 10. Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducer. 11. Patient with known interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 12. Patient with known myelodysplastic syndrome/acute myeloid leukemia. 13. Patient with history/ risk of venous thromboembolic events. 14. 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. 15. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery. 16. History of other malignancies in the last 5 years (Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible). 17. Patient with serum positivity for Hepatitis B, C or HIV. 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. 19. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication. 20. 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. 21. Use of grapefruit and grapefruit containing products within 07 days prior to the first dose of study medication. 22. Participation in any investigational drug study within 30 days prior to screening. 23. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 24. History of difficulty wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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