CTRI/2021/08/035525进行中（未招募）不适用
A randomized, open label, multi-center, two-treatment, three period, three-sequence, reference replicate, multiple dose, steady-state, bioequivalence (BE) study of Olaparib Tablets 150 mg (2x150 mg tablets) of Natco Pharma Limited with LYNPARZA® (Olaparib) tablets 150 mg (2x150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, in male or female patients with ovarian cancer or breast cancer or prostate cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 18
- 主要终点
- To assess the bioequivalence and characterize the pharmacokinetic profiles of Olaparib tablets 150 mg (2x150 mg tablets) of Natco Pharma Limited with LYNPARZA® (Olaparib) tablets 150 mg (2x150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
研究概览
简要总结
Natco Pharma Limited. has developed the test product Olaparib tablets 150 mg similar to that of the reference product LYNPARZA® (Olaparib) tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 for US regulatory submission. This study is being conducted to characterize the pharmacokinetic profile of Sponsor’s test product in comparison to the reference product after multiple oral dose administration in male or female patients with ovarian cancer or breast cancer or prostate cancer to assess the bioequivalence.
Study has been designed as per USFDA OGD recommendation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients will be considered eligible for the study based on the following criteria:
- •Willing and able to provide written informed consent prior to any study-related activities being performed.
- •Male or female patients aged 18 years and older and having Body mass index (BMI) Greater than or equal to 17 calculated as weight in kg per height in m
- •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 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 advanced ovarian cancer who have been treated with three or more prior lines of 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 a prior endocrine therapy or be considered inappropriate for endocrine therapy.
- •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.
- •Patients with established dosing regimen who are already receiving a stable dose of olaparib tablets (2x150 mg tablets) 300 mg twice daily.
- •Able to swallow and retain oral medication.
- •Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal to
- •Life expectancy of Greater than 90 days.
- •Acceptable hematology status: a.
- •Hemoglobin Greater than or equal to 9 g per dL b.
- •Platelet count Greater than or equal to 1, 00,000 cells per microliter
- •Acceptable liver function: a.
- •Alanine aminotransferase Less than or equal to 2X upper limit of normal b.
- •Aspartate aminotransferase (AST) Less than or equal to 2X ULN c.
- •Bilirubin Less than 1.2 mg per dL d.
- •Alkaline phosphatase Less than or equal to 2X ULN
- •Patients with creatinine clearance Greater than or equal to 60 mL per minute.
- •Female patients with negative serum pregnancy test
- •Male patients with female partners of reproductive potential must agree to use condoms from screening, during study and for at least 03 months after treatment discontinuation.
- •Women of child bearing potential, (defined as women physiologically capable of becoming pregnant) they must agree to use effective method of contraception during dosing and for at least 06 months after the treatment discontinuation) practicing two acceptable methods of contraception.
- •Acceptable methods of contraception are: a.
- •Intrauterine device or intrauterine system b.
- •Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) c.
- •Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) plus one additional contraception method (hormonal or barrier method) d.
- •Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation e.
- •Female patients of non-childbearing potential are not required to use effective method of contraception during the study.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •Known hypersensitivity to Olaparib or to any of the excipients.
- •Patients with Pneumonitis.
- •History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •Current or anticipated use of any of the prohibited medications during study participation (Appendix B)
- •Patients who are breastfeeding and lactating.
- •Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •Patients with Surgical or other non-healing wounds.
- •Known CNS metastasis.
- •Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •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 Greather than or equal to9 g per 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).
- •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.
- •Patient tested positive for Coronavirus infection (COVID-19).
- •Any other condition(s) which could significantly interfere with Protocol compliance.
- •Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •Loss of Greather than or equal to350 mL (1 unit) of blood within 90 days of enrolment in the study.
- •Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
结局指标
主要结局
To assess the bioequivalence and characterize the pharmacokinetic profiles of Olaparib tablets 150 mg (2x150 mg tablets) of Natco Pharma Limited with LYNPARZA® (Olaparib) tablets 150 mg (2x150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
时间窗: A total of forty-five (45) blood PK blood samples of 3.0 mL from each patient will be | Collected during the study duration. Sample will be collected on day 4, 5, 6, 10, 11, 12, 16, 17, 18.
次要结局
- To assess the safety and tolerability of test product compared to reference product by monitoring adverse events(A total of forty-five (45) blood PK blood samples of 3.0 mL from each patient will be)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor StatusRelapsed Ovarian Cancer, BRCA Mutation, Platinum SensitivityNCT02983799AstraZeneca272
进行中（未招募）
2 期
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube CancerFallopian Tube CancerNeoadjuvant TreatmentOvarian CancerDebulking Surgical ProceduresNCT02489006University Health Network, Toronto71
已完成
2 期
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) StatusColorectal CancerNCT00912743AstraZeneca33
已完成
2 期
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast CancerBreast NeoplasmsNCT00494234AstraZeneca54
已完成
1 期
A Pilot Bioequivalence Study of PomalidomideBioequivalenceNCT03424928Jiangsu Simcere Pharmaceutical Co., Ltd.12