Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Olaparib tablets, 150 mg by Sandoz India Private Limited: Two 150 mg tablets twice daily
for 15 days
Control Intervention1: Lynparza(olaparib) tablets 150
mg AstraZeneca Pharmaceuticals
Sponsors
Lek Pharmaceuticals dd
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with already diagnosed or known cases of Ovarian Cancer: Maintenance treatment of adult patients 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 are in response (complete or partial) following completion of first-line platinum-based chemotherapy. OR Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. OR Breast Cancer: Monotherapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. OR Monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy 2. Non-smoking, non-pregnant, non-lactating female patient more than or equal to 18 years of age with a body mass index (BMI) in the range of 18.50 to 30.00 kg/m2 (both inclusive). 3. Able to give written informed consent for participation in the trial and willing to adhere protocol requirement. 4. Patient having an estimated survival of at least 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Adequate organ and bone marrow function at the time of eligibility assessment 7. Women of non-child bearing potential with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months. 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
Exclusion criteria
Exclusion criteria: - History of known hypersensitivity to Olaparib or its components which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study. - Patients with severe hepatic impairment (Child Pugh classification category C), moderate renal impairment and severe renal impairment or end-stage renal disease - Blood loss within 90 days prior to first dosing in Period I for the current study. - 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 1. - Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics and establish bioequivalence of the Test Product (Olaparib tablets, 150 mg) relative to that of Reference Product (Lynparza® (olaparib) tablets 150 mg) in patients with ovarian or breast cancer.Timepoint: Pre-dose (0.00 hr) 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 patients and to assess safety of each of the two formulations.Timepoint: To monitor the adverse events of patients and to assess safety of each of the two formulations up to day 24. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Limited
Outcome results
None listed