CTRI/2025/01/079400进行中（未招募）不适用
An Open-Label, Randomized, Two-Period, Three- Treatment, Two-Sequence, Crossover, Multicenter, Multiple-Dose, Fully Replicate, Steady State Bioequivalence Study of Test Products (T1 and T2) Olaparib Tablets 150 mg (2 X 150 mg tablets) of Biocon Pharma Limited, India and Lynparza® (Olaparib) Tablets 150 mg (2X150 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 Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Cmaxss and AUC0-tauss
研究概览
简要总结
This is an open label, multicenter, randomized, three-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 Fasting Condition.
Biocon 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 (T1 & T2) of Biocon 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 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive).
- •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 is 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 has been treated with neoadjuvant or adjuvant chemotherapy.
- •OR Patient with deleterious or suspected deleterious gBRCAm, HER2- negative metastatic breast cancer, who has been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
- •Note: Patient with hormone receptor (HR)-positive breast cancer should has 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 has 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) 18.0-30.0 kg/m2 (both inclusive).
- •Patient with life expectancy less than 90 days.
- •Acceptable hematology status: a.
- •Hemoglobin less than or equal to 9 g/dL.
- •Absolute neutrophil count (ANC) less than or equal to 1500 cells/µL.
- •Platelet count less than or equal to 1,00,000 cells/µL.
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) greater than or equal to 2X Upper Limit Normal (ULN) (greater than or equal to 5 X ULN for liver metastasis).
- •Aspartate aminotransferase (AST) greater than or equal 2X ULN (greater than or equal 5 X ULN for liver metastasis).
- •Alkaline phosphatase greater than or equal 2X ULN.
- •Calculated serum creatinine clearance less than or equal to 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl equal to (140 –Age) x mass (Kilogram weight) per 72 x S.Cr in (mg/dl), if female x 85 percent
- •Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal
- •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.
- •â€¢ 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€¢ 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 (except abiraterone or prednisone or prednisolone), radiotherapy within 4 weeks prior to study treatment.
- •Patient with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) less than or equal to grade 2), with the exception of alopecia, caused by previous cancer therapy.
- •Patient with deleterious or suspected deleterious gBRCA mutation and advanced ovarian cancer who has been treated with three or more prior lines of chemotherapy.
- •QTc (Heart Rate Corrected QT interval) less than 450 msec (male) or less than 470 msec (female) or family history of long QT syndrome.
- •QT interval will be calculated with Bazett’s 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 known interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- •Patient with known 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 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 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).
- •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.
- •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.
- •Use of grapefruit and grapefruit containing products within 07 days prior to the first dose of study medication.
- •Participation in any investigational drug study within 30 days 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 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 investigator’s 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 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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