Health Condition 1: C504- Malignant neoplasm of upper-outerquadrant of breast
Conditions
Sponsors
BDR pharmaceuticals International Pvt Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or non pregnant non lactating female between 18 to 65 years of age both inclusive 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 germline BRCA mutation before olaparib treatment is initiated OR 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 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 olaparib treatment is initiated. OR Patient 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 Patient 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 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. 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 Patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated mCRPC in whom chemotherapy is not clinically indicate Note: BRCA mutations must be confirmed before olaparib treatment is initiated Patient with body mass index (BMI) 18.5 to 30.0 kg/m2 both inclusive Patient 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 Patient with life expectancy greater than or equal to 3 months Acceptable hematology status Hemoglobin greater than or equal to 9 g/dL Patients with pancreatic cancer will be eligible if they meet acceptable liver function test criteria Calculated serum creatinine clearance greater than or equal to 50 mL/min using Cockcroft gault formula which is as follows Formula of creatinine clearance Crcl eqauls 140 Age x mass Kilog
Exclusion criteria
Exclusion criteria: Patient with a known hypersensitivity to olaparib or any of the excipients of the product Patient receiving any systemic chemotherapy except abiraterone or prednisone or prednisolone or radiotherapy within 4 weeks prior to stabilization Patient who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization Patient with any ongoing toxicities CTCAE Common Terminology Criteria for Adverse Events greater or equal to grade 2 with the exception of alopecia caused by previous cancer therapy Patient who has administered any live vaccine within 28 days prior to randomization Patient with interstitial pneumonia or symptomatic diffuse fibrosis of the lungs Patient with known myelodysplastic syndrome acute myeloid leukemia Patient with known history risk of venous thromboembolic events Patient with symptomatic uncontrolled brain metastases Patient can receive stable doses of steroids before and during study as long as these were started at least 4 weeks prior to treatment Patient with spinal cord compression Major surgery within 2 months of screening or not having recovered from any undesirable or harmful effects of any previous major surgery Patients who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of olaparib during the study 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 Current or anticipated use of any prohibited medications during study participation Patient with serum positivity for Hepatitis B virus HBV Hepatitis B surface antigen HBsAg or Hepatitis B core antibody anti HBc Hepatitis C virus HCV anti-HCV antibody or Human Immunodeficiency Virus HIV Any significant disease or condition which might compromise the haemopoeitic gastrointestinal eg pancreatitis renal hepatic cardiovascular respiratory central nervous system diabetes psychosis or any other body system 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 year prior to screening Use of potent CYP3A4 inhibitors or inducers caffeine/xanthine products recreational drugs within 48 hours or dietary items affecting CYP enzymes or P glycoprotein eg grapefruit pomegranate St Johns wort within 7 days prior to randomization Participation in any investigational drug study within 30 days prior to screening Donation or loss of blood or plasma of one unit about 450 mL whole blood or 220 mL plasma in the previous 90 days prior to randomization History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture Patient who is unable to swallow orally administered medication and Patient with gastrointestinal disorders likely to interfere with absorption of the investigational product Any food allergy intolerance restriction or special diet that in the opinion of the Investigator could contraindicate the Patients participation in this study Any other condition or any clinically significant abnormalities in ECG or laboratory parameters that in the investigators judgment might increase the risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Bioequivalence of Olaparib Tablets 300 mg 150 mg x 2 Twice daily Manufactured by BDR Pharmaceuticals International Pvt Ltd India with LYNPARZA Olaparib Tablets 300 mg 150 mg x 2 Twice daily Marketing Authorization Holder Astrazeneca Ab Gartunavagen Sodertalje Sweden Se 151 85 in Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas Under Fed ConditionsTimepoint: 64 Time points Day 04 00 00 Hrs Day 05 00 00 Hrs Day 06 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 07 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 11 00 00 Hrs Day 12 00 00 Hrs Day 13 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 14 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product In Adult Patients with carcinoma of the ovary breast prostate or adenocarcinoma of the pancreas Under Fed ConditionsTimepoint: 64 Time points Day 04 00 00 Hrs Day 05 00 00 Hrs Day 06 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 07 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 11 00 00 Hrs Day 12 00 00 Hrs Day 13 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs Day 14 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 07 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed