CTRI/2023/01/048872进行中（未招募）未知
A randomized, open-label, multi-center, two-treatment, two-period, two-sequence, two-way cross over, multiple-dose, steady-state, bioequivalence (BE) study of Olaparib Tablets 150 mg of Qilu Pharmaceutical (Hainan) Co., Ltd with LYNPARZA® (Olaparib) tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, in male or female patients with ovarian cancer or breast cancer or pancreatic adenocarcinoma or prostate cancer.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
- •Patients with a recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
- •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
- •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.
- •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
- •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
排除标准
- •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)
研究者
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