CTRI/2022/03/040741已完成不适用
A randomized, open label, multi-centre, two-treatment, two-period, two-sequence, two-stage, multiple dose, steady-state, crossover, bioequivalence study of Olaparib tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (olaparib) tablets 150 mg (AstraZeneca Pharmaceuticals LP), in patients with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 19
- 主要终点
- 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 BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
研究概览
简要总结
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer. The primary objective of this study is 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).
Patients will be enrolled after providing written informed consent and treatments will be allocated to
patient by carrying out randomization using statistical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.First-Line Maintenance Treatment of BRCA mutated Advanced Ovarian Cancer maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum based chemotherapy.
- •OR Maintenance Treatment of Recurrent Ovarian Cancer maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum based chemotherapy.
- •OR Advanced Germline BRCA mutated Ovarian Cancer After 3 or More Lines of Chemotherapy treatment of adult patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
- •OR Germline BRCA-mutated HER2 negative Metastatic Breast Cancer treatment of adult 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 positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
- •2.Non-smoking, non-pregnant, non-lactating female 3.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 per m2 (both inclusive).
- •4.Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements.
- •5.Patient having an estimated survival of at least 3 months 6.Adequate organ and bone marrow function based upon the following laboratory criteria at the time of eligibility assessment prior to dosing in period 1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •7.Women of non child bearing potential with documented evidence of hysterectomy or bilateral salpingectomy or 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 (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to IMP administration] sexual partner) for at least 4 weeks prior to IMP administration, during the study and up to 6 months after the last dose of IMP.
- •Cessation of birth control after this point should be discussed with a responsible physician.
排除标准
- •Patients who meet any of the following criteria at screening will not be enrolled in the study: 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.
- •Usage of strong and moderate CYP3A4 inhibitors (e.g., cimetidine, ciprofloxacin, grapefruit juice) or strong and moderate CYP3A4 inducers (e.g., carbamazepine, phenytoin, St. John‟s Wort, rifampicin) within 30 days prior to first dosing in Period
- •Pregnant or lactating females.
- •History or presence of clinically significant lactose, galactose, or fructose intolerance.
结局指标
主要结局
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 BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
时间窗: Pre-dose (0.00 hr) on day | 1,6,7,8,14,15 and 16 and | Post-dose on day 8 and day 16.
次要结局
- Number of adverse events(and serious adverse events)
研究者
研究点 (19)
Loading locations...
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