Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Olaparib Tablets: Dosage:150 mg,
Frequency: 2x150 mg tablets twice-daily,
Route of Administration: Oral,
Duration of Therapy: 12 Days.
Control Intervention1: LYNPARZA ® (Olaparib) tab
Sponsors
Qilu Pharmaceutical Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to any study-related activities being performed 2. Male or female patients aged 18 years and older and having Body mass index (BMI) greaterthan or equal to 17 calculated as weight in kg per height in m2 3. Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy OR Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and or genomic instability. OR Patients with a recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy OR Patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy OR Patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy. OR Patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen OR Patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone 4. Patients with an established dosing regimen who already are receiving a stable dose of Olaparib tablets 300 mg twice daily or patients not stabilized on Olaparib treatment who are eligible to receive Olaparib therapy as per inclusion criteria 3 5. Able to swallow and retain oral medication 6. Eastern Cooperative Oncology Group (ECOG) performance status lessthan or equal to 2 7. The life expectancy of greaterthan 90 days. 8. Acceptable hematology status a. Hemoglobin greaterthan or equal to 9 g per dL b. Absolute neutrophil count (ANC) greaterthan or equal to 1500 cells per micro L c. Platelet count greaterthan or equal to 1,00,000 cells per micro L d. Absolute white blood cell (WBC) count of greaterthan or equal to 3000 cells per micro L 9. Acceptable liver function: a. Alanine aminotransferase (ALT) lessthan or equal to 2X upper limit of normal (ULN) (lessthan or equal to 5X ULN in case of liver metastasis) b. Aspartate aminotransferase (AST) lessthan or equal to 2X ULN (lessthan or equal to 5X ULN in case of liver metastasis) c. Bilirubin lessthan or equal to 1.5 X ULN (lessthan or equal to 5X ULN in case of liver metastasis) d. Alkaline phosphatase lessthan or equal to 2X ULN (lessthan
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Olaparib or any of the excipients 2. Patients with history of Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) 3. Patients with Pneumonitis 4. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus, etc.) 5. Current or anticipated use of any of the prohibited medications during study participation (Appendix B) 6. Patients who are breastfeeding and lactating 7. Major surgical procedure (including periodontal) within 28 days of the first dose of Investigational Product 8. Patients with Surgical or other non-healing wounds 9. Known CNS metastasis 10. Prostate cancer patients with history of Venous thromboembolic events within 2 months prior to screening 11. 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 12. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin reater than or equal to 9 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v5.0) 13. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study 14. Patients with confirmed novel coronavirus infection (COVID-19) 15. Any other condition(s) which could significantly interfere with Protocol compliance 16. Participation in any clinical study within 90 days before the first dose of Investigational Product 17. Loss of reater than or equal to 350 mL (1 unit) of blood within 90 days of enrolment in the study 18. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability of Olaparib tablets 150 mg of Qilu Pharmaceutical (Hainan) Co., Ltd. with LYNPARZA® (Olaparib) tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850Timepoint: Day 6 & 12; Time points are Pre-dose blood sample (00.00) in the morning [Within 10 minutes prior to dosing], 0.5hrs, 1.0 hrs, 1.33hrs, 1.67hrs, 2.0hrs, 2.33hrs, 2.67hrs, 3.0hrs, 3.5hrs, 4.0hrs, 4.5hrs, 5.0hrs, 6.0hrs, 8.0hrs, 10.0hrs, 12.0hrs [Post-dose blood samples after the morning dose ± 02 minutes] | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of patientsTimepoint: Day 6 & 12; Time points are Pre-dose blood sample (00.00) in the morning [Within 10 minutes prior to dosing], 0.5hrs, 1.0 hrs, 1.33hrs, 1.67hrs, 2.0hrs, 2.33hrs, 2.67hrs, 3.0hrs, 3.5hrs, 4.0hrs, 4.5hrs, 5.0hrs, 6.0hrs, 8.0hrs, 10.0hrs, 12.0hrs [Post-dose blood samples after the morning dose ± 02 minutes] | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed