CTRI/2023/10/058337已完成不适用
A Double Blind, Multicenter, Randomized, Three-Treatment, Three-Period, Six-Sequence, Steady-State Bioequivalence Study of Test Product (A) Olaparib Tablets 150 mg (2 into 150 mg tablets) of Natco Pharma Limited, India with Reference Product (B1) Lynparza tablets (Olaparib) 150 mg (2 into 150 mg tablets) of AstraZeneca do Brasil Ltda and Reference Product (B2) PrLYNPARZA® Olaparib Tablets 150 mg (2 into 150 mg tablets) of AstraZeneca Canada Inc. 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
- 已完成
- 入组人数
- 42
- 试验地点
- 20
- 主要终点
- CmaxSS, Cminss and AUC
研究概览
简要总结
This is a double blind, multicenter, randomized, three-treatment, three-period,six-sequence, steady-state bioequivalence study in adult male and femalepatients with ovarian cancer or breast cancer or prostate cancer under fastingcondition.
Natco Pharma Limited, India isseeking approval for the generic drug application of Olaparib Tablets 150 mg,for which demonstration of bioequivalence to the reference listed productsLynparza tablets (Olaparib) 150 mg (2*150 mg tablets) of AstraZeneca do BrasilLtda, and PrLYNPARZA® Olaparib Tablets 150 mg (2*150 mg tablets) ofAstraZeneca Canada Inc., will be required.
This pharmacokinetic study has been designed tocompare multiple-dose PK parameters and safety of test formulation OlaparibTablets 150 mg of Natco Pharma Limited, India, with Reference Product (B1) Lynparza tablets (Olaparib) 150 mg (2*150mg tablets) of AstraZeneca do Brasil Ltda, and Reference Product (B2) PrLYNPARZA® Olaparib Tablets 150 mg (2*150 mg tablets) ofAstraZeneca Canada Inc. in adult male and female patients with ovariancancer or breast cancer or prostate cancer under fasting condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: Patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •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 platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response 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.
- •Patients with hormone receptor (HR)-positive breast cancer should have progressed on 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 of abiraterone and prednisone or prednisolone for treatment of metastatic castration-resistant prostate cancer.
- •Patient with body mass index (BMI) 18.5 to 30.0 kg/m2 (both inclusive).
- •Patient with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 into 150 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 having body weight ≥ 45 Kg.
- •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 Cockroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl equals to (140-Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl) if ‘female’ x 85 percentage.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to study).
- •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 of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL.
- •â€¢ Chemotherapy-induced menopause with > 1 year interval since last menses.
- •â€¢ At least 6 months post-surgery following bilateral oophorectomy with or without hysterectomy.
- •Patient who had taken COVID 19 vaccine, must recovered from vaccine related adverse events before being screened for the study.
- •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
- •Exclusion Criteria: Patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •Patient with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue).
- •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.
- •Current or anticipated use of any prohibited medications during study participation.
- •Female patient who is breastfeeding and lactating.
- •Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducer.
- •Patient with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) ≥ grade 2), with the exception of alopecia, caused by previous cancer therapy.
- •QTc (Heart Rate Corrected QT interval) > 450 msec (male) or > 470 msec (female) or family history of long QT syndrome.
- •QT interval will be calculated with Bazett’s Formula.
- •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 study starting and patient must have 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.
- •Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, dietary items that have effect on P450 enzymes (e.g., pomegranate, star fruit, seville oranges) & PGP (P-Glycoprotein) efflux pump (e.g., St. John’s wort) 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.
- •Patient who has received an investigational drug or participation in drug research study within 06 months prior to the first dose of study medication.
- •Donation of blood (excluding volume drawn at screening for this study) within 06 months prior to the first dose of study medication.
- •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.
- •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, Cminss and AUC
时间窗: 3 week
次要结局
- Cminss, Tmaxss, Cavss, swing(3 week)
研究者
研究点 (20)
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