CTRI/2024/09/073640已完成不适用
An Open-Label, Multicenter, Randomized, Two-Treatment, Two-Period, Two-Sequence, Steady-State Crossover Bioequivalence Study of Test Product Olaparib Tablets 150 mg of Dr. Reddy’s Laboratories Ltd., India with Reference Product Lynparza® (Olaparib Tablets 150 mg) of AstraZeneca Pharmaceuticals, Wilmington, USA in Adult Patients with Ovarian Cancer or Breast Cancer or Pancreatic Cancer or Prostate Cancer under Fasting Condition
Dr. Reddy’s Laboratories Ltd5 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年11月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Primary Endpoint(s):
研究概览
简要总结
This is an open label, multicenter, randomized, two-treatment, two-period, two-sequence, steady-state bioequivalence study in adult patients with Ovarian Cancer or Breast Cancer or Pancreatic Cancer or Prostate Cancer under Fasting Condition.
Dr. Reddy’s Laboratories Ltd., India is seeking approval for the generic drug application of Olaparib Tablets 150 mg, for which demonstration of bioequivalence to the reference listed product Lynparza® (Olaparib) Tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 will be required.
This pharmacokinetic study has been designed to compare multiple-dose PK parameters and safety of test formulation Olaparib Tablets 150 mg of Dr. Reddy’s Laboratories Ltd., India, with Reference Product Lynparza® (Olaparib) Tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in adult patients with Ovarian Cancer or Breast Cancer or Pancreatic Cancer or Prostate Cancer under Fasting Condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female between 18-75 years of age (both inclusive) who are willing to provide informed consent to participate in the study.
- •Patient 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 first-line platinum-based chemotherapy.
- •OR Patient with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
- •OR Patient 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 Patient with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
- •Note: Patient with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
- •OR Patient 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 Patient 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.
- •Patient with an established dosing regimen who already are receiving a stable dose of olaparib or if naïve to olaparib, are willing to undergo at least 15 days of stabilization period with olaparib tablets, 150 mg (Dose: 600 mg/day).
- •Patient with body mass index (BMI) 18-30 kg/m2 (both inclusive).
- •5.Adequate bone marrow and organ function a.
- •Hemoglobin ≥ 9 g/dL or gm% with no blood transfusions in the previous 28 days prior to randomization b.
- •Absolute Neutrophil Count c.
- •White blood cells d.
- •Platelets e.
- •Total bilirubin ≤ 1.5 x Upper Limit Normal (ULN) or ≤ 3 x ULN in the presence of liver metastasis f.
- •AST/ ALT ≤ 2.5 x ULN, if liver metastases then ≤ 5 x ULN g.
- •Serum creatinine ≤ 1.5 x ULN
- •Calculated serum creatinine clearance
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Male patient if sexually active with a female of child-bearing potential must agree to use barrier method of contraception throughout the study period and for at least 3 months after last dose of study drug.
- •Female patient with postmenopausal status or female patient of child-bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug.
- •Postmenopausal with spontaneous amenorrhea for at least one year, or.
- •6 months to 12 months of spontaneous amenorrhea with serum c.
- •Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or.
- •Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations.
排除标准
- •Patient with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •Patient receiving any systemic chemotherapy, radiotherapy within 4 weeks before randomization.
- •Concomitant use of known strong or moderate CYP3A4 (Cytochrome P4503A4) inhibitors or inducer within 14 days before start of study medication.
- •Patient with any ongoing toxicities except alopecia
- •Patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- •Patient with history/ risk of venous thromboembolic events.
- •Patient with symptomatic uncontrolled brain metastases.
- •Patient can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment.
- •Patient with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- •Major surgery within 2 months of study starting and patient must have recovered from any undesirable or harmful effects of any major surgery.
- •Patient with serum positivity for Hepatitis B, C, or HIV at screening visit.
- •Consumption of any grapefruit, star fruit, grape fruit juice, seville oranges, and seville orange juice and its products within 07 days prior to first dosing of Period-I.
- •Ingestion of any alcoholic food (e.g. plum pudding, cake, chocolate containing alcohol) or beverage containing alcohol or utilize recreational drugs, caffeine or xanthine containing food or beverage within the 48 hours prior to randomization.
- •History of drug dependence, history of alcoholism [more than 2 drinks per day, 1 drink is defined as 360 mL of beer, 240 mL of malt liquor, 150 mL of wine and 45 mL of distilled spirits (gin, rum, vodka, whiskey, etc.)] in the past 1 years prior to screening.
- •Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days.
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
- •Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system, with the exception of the cancer under treatment.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patient’s participation in this study.
- •Any other condition that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
Primary Endpoint(s):
时间窗: 2 Week
Cmaxss and AUC0-tauss
时间窗: 2 Week
Secondary Endpoint(s):
时间窗: 2 Week
Cminss, Tmaxss, Cavss, degree of Fluctuation, and Swing
时间窗: 2 Week
次要结局
- Safety and tolerability(3 Week)
研究者
Dr Dharmesh Domadia
Cliantha Research Ltd.,
研究点 (5)
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