CTRI/2024/09/073986已完成不适用
A Randomized, Open-Label, Multicenter, Two- Treatment, Two-Period, Two-Sequence, Crossover, Steady-State Bioequivalence Study of Test Product Olaparib Tablets 150 mg (2 x150 mg tablets) of Natco Pharma Limited, India with Reference Product Lynparza (Olaparib) Tablets 150 mg (2 x 150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in Adult Male and Female Patients with Ovarian Cancer or Breast Cancer or Prostate Cancer Under Fed Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 25
- 主要终点
- Cmaxss and AUC0-tauss
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 Male and Female Patients with Ovarian Cancer or Breast Cancer or Prostate Cancer Under Fed Condition.
Natco Pharma Limited, 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 Natco Pharma Limited, India with Reference Product Lynparza® (Olaparib) Tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in Adult Male and Female Patients with Ovarian Cancer or Breast Cancer or Prostate Cancer Under Fed 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female between 18-65 years of age.
- •Patient with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who is 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 and is in maintenance treatment.
- •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: 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 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.
- •OR Combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
- •Patient with body mass index (BMI) 18.0 to 30.0 kg/m2 (both inclusive).
- •Patient with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 x150 mg tablets) 300 mg twice daily or willing to undergo at least 15 days of stabilization period with olaparib tablets, 150 mg.
- •NOTE: For the patients who will enter into the stabilization period, the criteria will be evaluated during screening part II
- •Patient with life expectancy less than 90 days.
- •Acceptable hematology status: a.
- •Hemoglobin ≥ 9 g/dL.
- •Absolute neutrophil count (ANC) ≥ 1500 cells/µL.
- •Platelet count ≥ 1,00,000 cells/µL.
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) ≤ 2X upper limit of normal (ULN).
- •Aspartate aminotransferase (AST) ≤ 2X ULN.
- •Alkaline phosphatase ≤ 2X ULN.
- •Calculated serum creatinine clearance ≥ 50 mL/min using Cockcroft-Gault formula
- •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 6 months after last dose of study drug.
- •Female with postmenopausal status or female 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 is defined by any one of the following: • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments • 6 months to 12 months of spontaneous amenorrhea with serum FSH levels less than 40 mIU/mL.
- •â€¢ Radiation-induced oophorectomy with last menses less than 1 year ago.
- •â€¢ Chemotherapy-induced menopause with less than 1 year interval since last menses.
- •â€¢ At least 6 months post-surgery following bilateral oophorectomy with or without hysterectomy.
- •Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations.
- •Patient/LAR willing to provide informed consent to participate in the study.
排除标准
- •Patient with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Patient who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to enrollment on study.
- •Patient who are 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 prior to study treatment.
- •Patient with any ongoing toxicities CTCAE ≥ grade 2 with the exception of alopecia, caused by previous cancer therapy.
- •QT interval will be calculated with Bazetts Formula.
- •Female patient who is breastfeeding and lactating.
- •Current or anticipated use of any prohibited medications during study participation.
- •Concomitant use of known potent CYP3A4 Cytochrome P4503A4 inhibitors or inducer.
- •Patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- •Patient with myelodysplastic syndrome/acute myeloid leukemia.
- •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 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 screening or not recovered from any undesirable or harmful effects of any major surgery
- •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.
- •Patient with known serum positivity for Hepatitis B, C or HIV.
- •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.
- •Ingestion of any caffeine or xanthine products i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc., recreational drugs within 48 hours prior to the first dose of study medication.
- •Use of grapefruit and grapefruit containing products within 07 days prior to the first dose of study medication.
- •Donation or loss of blood or plasma of one unit about 450 mL whole blood or 220 mL plasma in the previous 60 days.
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
- •Institutionalized patient.
- •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 investigators judgment, 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
Cmaxss and AUC0-tauss
时间窗: 2 Weeks
次要结局
- Cminss, Tmaxss, Cavss, degree of Fluctuation, and Swing(2 Weeks)
研究者
Dr Dharmesh Domadia
Cliantha Research Ltd.,
研究点 (25)
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