CTRI/2025/08/092830尚未招募不适用
A Double-Blind, Randomized, Four-Period, Two-Treatment, Two-Sequence, Crossover, Multicenter, Multiple-Dose, Steady State Bioequivalence Study of Olaparib Tablets 150 mg of Zydus Lifesciences Limited with PrLYNPARZA® (Olaparib) Tablets 150 mg of AstraZeneca Canada Inc., in Adult Participants with Cancer and Stable on Olaparib Therapy Under Fasting and Fed Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 17
- 主要终点
- Cmaxss, Cminss and AUC0-tauss
研究概览
简要总结
This is a randomized, double-blind, four-period, two-treatment, two-sequence, crossover, multicenter, multiple-dose, steady state bioequivalence study.
The Zydus Lifesciences Limited, India has developed Olaparib Tablets 150 mg and is seeking approval for its generic drug application in Health Canada. This formulation contains the same active pharmaceutical ingredient (API) as the existing medication PrLYNPARZA® (Olaparib) Tablets 150 mg of AstraZeneca Canada Inc. necessitating a demonstration of bioequivalence to the reference product.
This pharmacokinetic study aims to compare multiple-dose PK parameters and safety of test formulation Olaparib Tablets 150 mg of Zydus Lifesciences Limited, India with PrLYNPARZA® Olaparib Tablets 150 mg (2*150 mg tablets) of AstraZeneca Canada Inc., in adult participants with cancer and stable on olaparib therapy under fasting and fed condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive).
- •Participant with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Note: Participants must have confirmation of germline BRCA mutation before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Note: Participant with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Note: Participants must have confirmation of BRCA mutation (identified by either germline or tumour testing) before olaparib treatment is initiated. OR Participant 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. Note: Platinum-sensitive relapse is defined as disease progression occurring at least 6 months following completion of platinum chemotherapy. OR Participant with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Note: Germline BRCA mutation must be confirmed before olaparib treatment is initiated. OR Participant with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. Note: BRCA or ATM mutations must be confirmed before olaparib treatment is initiated. OR In combination with abiraterone and prednisone or prednisolone for the treatment of adult participants with deleterious or suspected deleterious germline and/or somatic BRCA mutated mCRPC in whom chemotherapy is not clinically indicated Note: BRCA mutations must be confirmed before olaparib treatment is initiated.
- •Participant with body mass index (BMI) 18.5 to 30.0 kg/m2 (both inclusive).
- •Participant with established dosing regimen who are already receiving a stable dose of olaparib tablets (2x150 mg tablets) 300 mg twice daily for at least 15 days or willing to undergo at least 15 days of stabilization period with olaparib tablets (2x150 mg tablets) 300 mg twice daily.
- •Participant with life expectancy greater than or equals to 3 months.
- •Acceptable hematology status: a. Hemoglobin greater than or equals to 10 g/dL with no blood transfusions in the previous 28 days prior to randomization. b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/µL. c. Platelet count greater than or equals to 1,00,000 cells/µL.
- •Acceptable liver function: a. Alanine aminotransferase (ALT) less than or equals to 2.5 x upper limit of normal (ULN) or less than or equals to 5 x ULN in the presence of liver metastases. b. Aspartate aminotransferase (AST) less than or equals to 2.5 x ULN or less than or equals to 5 x ULN in the presence of liver metastases. c. Total bilirubin less than or equals to 1.5 x Upper Limit Normal (ULN) or less than or equals to 3 x ULN in the presence of liver metastasis. d. Alkaline phosphatase less than or equals to 2 x ULN.
- •Calculated serum creatinine clearance greater than or equals to 50 mL/min (using Cockcroft-Gault formula) which is as follows: Formula of creatinine clearance: Crcl equals to (
- •Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if female x 85 percent.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to
- •Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to screening).
- •Male participant 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 participant with postmenopausal status or female of child bearing potential with negative pregnancy test must agree to practice two 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: a. Postmenopausal with spontaneous amenorrhea for at least one year, or b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU/mL. c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or. d. Total hysterectomy and an absence of bleeding for at least 3 months
- •Participant willing and able to comply with the protocol requirements.
- •Participant/LAR willing to provide informed consent to participate in the study.
排除标准
- •Participant with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), or radiotherapy within 4 weeks prior to stabilization.
- •Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization.
- •Participant with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) greater than or equals to grade 2), with the exception of alopecia, caused by previous cancer therapy.
- •Participant with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- •Participant with known myelodysplastic syndrome/acute myeloid leukemia.
- •Participant with known history/ risk of venous thromboembolic events.
- •Participant with symptomatic uncontrolled brain metastases.
- •Participant can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment.
- •Participant 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 participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible).
- •Current or anticipated use of any prohibited medications during study participation.
- •Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducers.
- •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, dietary items that have effect on P450 enzymes (e.g., pomegranate, star fruit, seville oranges) and PGP (P-Glycoprotein) efflux pump (e.g., St. Johns wort) within 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.
- •Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
- •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.
- •Participant who is unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the participants participation in this study.
- •Any other condition or any clinically significant abnormalities in ECG or laboratory parameters that, in the investigators judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Institutionalized participant.
结局指标
主要结局
Cmaxss, Cminss and AUC0-tauss
时间窗: 3 weeks
次要结局
- Cpdss and Tmaxss
研究者
Dr Dharmesh Domadia
Cliantha Research Limited
研究点 (17)
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