Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C61- Malignant neoplasm of prostate Health Condition 3: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Olaparib tablets 150 mg (Sandoz Private Limited): 150 mg film coated tablet, twice a day for 14 days
Control Intervention1: Lynparza tablets (Olaparib) 150 mg of AstraZeneca do Brasil L
Sponsors
Lek Pharmaceuticals d.d.
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with already diagnosed or known cases of - Ovarian Cancer: Maintenance treatment of adult participants with ovarian carcinoma (including fallopian tube or primary peritoneal carcinoma), newly diagnosed, high-grade - grade 2 or higher advanced, with BRCA mutation, who respond - complete or partial response to first line, platinum based chemotherapy. OR Maintenance treatment of adult participants with serous ovarian carcinoma-including fallopian tube or primary peritoneal or endometrioid carcinoma, high grade - grade 2 or higher, relapsed, platinum-sensitive and responsive - complete or partial response to platinum-based chemotherapy. OR Breast Cancer: Adjuvant treatment of adult participants with HER2-negative high-risk early breast cancer with BRCA mutation, who were previously treated with neoadjuvant or adjuvant chemotherapy. OR Treatment of adult participants with HER2-negative, metastatic breast cancer with a germline mutation in BRCA gene - pathogenic or suspected pathogenic previously treated with chemotherapy. These participants may have received chemotherapy in a neoadjuvant, adjuvant or metastatic setting. Participants with hormone receptor-positive breast cancer, must have been treated with prior endocrine therapy or be considered unsuitable for endocrine therapy. OR Prostate cancer: Monotherapy for the treatment of adult participants with metastatic castration-resistant prostate cancer and BRCA1/2 mutation involved in homologous recombination - germline and/or somatic, whose disease progressed after prior treatment with a new hormonal agent. 2. Non-smoking, non-pregnant, non-lactating participant greater than or 18 years of age with a BMI in the range of 18.50 to 30.00 kg per m sqaure- both inclusive. 3. Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements. 4. Participant having an estimated survival of at least 3 months. 5. Eastern Cooperative Oncology Group performance status of 0-2. 6. Adequate organ and bone marrow function based upon the laboratory criteria at the time of eligibility assessment. 7. Absence of blood transfusion in the 28 days prior to randomization. 8. Women of non-child bearing potential with documented evidence of hysterectomy or bilateral oophorectomy at least 6 months prior to IMP administration or postmenopausal -defined as 12 consecutive months of spontaneous amenorrhea without medical explanation for at least one year. OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy - oral, transdermal or implanted hormonal contraceptives in conjunction with a secondary method; non-hormonal intrauterine device + condom or diaphragm with spermicide; condom + diaphragm with spermicide; absolute sexual abstinence or sterile at least 6 months prior to IMP administration - sexual partner for at least 4 weeks or 3 months for oral contraceptives prior to stabilization medication/IMP administration, during the study and for 6 months after the last dose of IMP. 9. Male participants must agree to not donate sperm and to use a condom when having sexual intercourse with a female partner who is pregnant or of child bearing potential from the first dose of stabiliz
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria at screening will not be enrolled in the study: 1. History of known hypersensitivity to Olaparib or its components which, in the opinion of the Investigator, would compromise the safety of the participant or the results of the study. 2. Participants found positive for HIV, Anti-HBc IgM, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening. 3. Have ongoing clinically significant adverse events due to prior treatments administered, as determined by the investigator. 4. Participants with Pneumonitis. 5. Participants with severe hepatic impairment - Child Pugh classification category C, moderate renal impairment and severe renal impairment or end-stage renal disease. 6. In the opinion of the Investigator, the participant will not be compliant with the requirements of the study procedures. 7. Blood loss of 1 unit or 350 ml within 90 days prior to first dosing in Period I for the current study. 8. Usage of strong and moderate CYP3A inhibitors e.g., cimetidine, ciprofloxacin, grapefruit juice or strong and moderate CYP3A inducers e.g., carbamazepine, phenytoin, St. John s Wort, rifampicin within 30 days prior to first dosing in Period I refer annexure XIII for full list of prohibited medications. 9. Pregnant or lactating females. 10. History or presence of alcoholism or drug abuse. 11. Difficulty in swallowing tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics and establish the bioequivalence between Lynparza (Olaparib) tablets 150 mg Sandoz Private Limited test formulation and Lynparza tablets (Olaparib) 150 mg of AstraZeneca do Brasil Ltda - reference product in participants with ovarian or breast or prostate cancer under fasting condition.Timepoint: Pre-dose on Day 1, 4, 5, 6, 7, 11, 12, 13 and 14 Post dose on Day 6, 7, 13 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events of participants and to assess safety of each of the two formulations.Timepoint: Adverse event monitoring and Safety assessment of the test or reference product will be done throughout the study duration | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical research Limited
Outcome results
None listed