Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C569- Malignant neoplasm of unspecifiedovary Health Condition 3: C259- Malignant neoplasm of pancreas, unspecified Health Condition 4: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Olaparib tablets 150 mg of Cdymax (India) Pharma Private Limited, India: An oral dose of test product Olaparib tablets 150 mg (two tablets) will be administered in the morning and eveni
Sponsors
USV Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female between 18-75 years of age inclusive who is willing to provide informed consent to participate in the study. 2. Adult patient 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: Patients must have confirmation of BRCA mutation identified by either germline or tumor testing before oral Olaparib treatment is initiated. Or Adult patient with platinum-sensitive relapsed 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 Adult patient with deleterious or suspected deleterious germline BRCA-mutated gBRCAm, human epidermal growth factor receptor 2 HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Note: Patients 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 Adult patient 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: Patients must have confirmation of a germline BRCA mutation before Olaparib treatment is initiated. Or Adult patient with deleterious or suspected deleterious germline BRCA-mutated gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum- based chemotherapy. Germline BRCA mutation must be confirmed before oral Olaparib treatment is initiated. Note: BRCA mutation must be confirmed before Olaparib treatment is initiated. Or Adult patient 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. BRCA or ATM mutations must be confirmed before oral Olaparib treatment is initiated. Note: BRCA or ATM mutations must be confirmed before Olaparib treatment is initiated. 3.Patient with an established dosing regimen who already is receiving a stable dose of Olaparib tablets, 150 mg or if na ve to Olaparib, is willing to undergo at least 10 days of stabilization period with Olaparib tablets, 150 mg Dose of Olaparib in the study 600 mg per day. 4. Patient having body mass index between 18.50 and 30.00 kg per m2, both inclusive. 5. Adequate bone marrow and organ function defined as follows at screening: Hemoglobin - Greater than or equal to 9.0 g per dL Absolute neutrophil count - Greater than or equal to 1.5 109 per L White blood cell count - Greater than 3 109 per L Platelet count - Greater than or equal to 100 109/L Total bilirubin - Less than or equal to 1.5 ULN in the presence of liver metastasis Aspartate aminotrans
Exclusion criteria
Exclusion criteria: 1. Patient with a known hypersensitivity to Olaparib or any of the excipients of the product. 2. Patient who is unable to swallow orally administered medication and patient with gastrointestinal/other disorders likely to interfere with absorption of the study medication. 3. Patient receiving any systemic chemotherapy, radiotherapy within 4 weeks before randomization. 4. Current or anticipated use of any prohibited medications during study participation. 5. Concomitant use of known strong or moderate CYP3A4 (Cytochrome P4503A4) inhibitors or inducer within 14 days before start of study medication (Appendix-4). 6. Patient with any ongoing toxicities except alopecia [CTCAE (Common Terminology Criteria for Adverse Events)] greater grade 2 caused by previous cancer therapy. 7. Patient with known cancer and/or metastases in lungs, or underlying pulmonary disease such as bronchial asthma, COPD, interstitial pneumonia or diffused symptomatic fibrosis of the lungs. 8. Patient with prior surgical procedures such as full or partial gastrectomy that may interfere with absorption of Olaparib. 9. Patient with recent history of substance abuse including alcohol, tobacco containing products or drug of abuse within 1 year before randomization (subjects with positive alcohol breath test or drug of abuse urine screen at check-in to housing of any period will be discontinued from the study period and may be discontinued from the study at Investigator and/or Medical Monitor discretion). 10. Patient with history of or current myelodysplastic syndrome/acute myeloid leukemia. 11. Patient with history/risk of venous thromboembolic events. 12. 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. 13. Major surgery within 2 months of study starting and patient must have recovered from any undesirable or harmful effects of any major surgery. 14. Patient with serum positivity for Hepatitis B, C, or HIV at screening visit. 15. Consumption of any grapefruit/pomelo or food products beverages containing these within 07 days prior to first dosing of Period-I and throughout the duration of the treatment period. 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 the first dose of study medication. 17. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days. 18. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 19. 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. 20. Participation in any investigational drug study within 30 days prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of Test product with Reference product in adult patients with ovarian, breast, pancreatic, or prostate cancer under fed condition.Timepoint: At Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Test product and Reference product in adult patients with ovarian, breast, pancreatic, or prostate cancer under fed condition.Timepoint: At Baseline, Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactMr Umakant Ghodke
USV Pvt Ltd
Outcome results
None listed