CTRI/2025/11/097436尚未招募不适用
A Randomized, Open-Label, Multicenter, Two treatment, Two-period, Two-sequence, Cross-Over, Steady State, Fully Replicate, Multiple Dose, Bioequivalence Study of Olaparib Tablets 150 mg (2x150 mg tablets) of Alembic Pharmaceuticals Limited, India with PrLynparza® Olaparib Tablets 150 mg (2x150 mg tablets) of AstraZeneca Canada Inc., Mississauga, ON L4Y 1M4, in Adult Participants with Carcinoma of the Ovary, Breast, Prostate or Adenocarcinoma of the Pancreas under Fasting Condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- To evaluate the bioequivalence of Olaparib Tablets 150 mg (2x150 mg tablets)
研究概览
简要总结
This study is being conducted to establish the bioequivalence of Olaparib Tablets 150 mg (2x150 mg tablets) of Alembic Pharmaceuticals Limited, India with PrLynparza Olaparib Tablets 150 mg (2x150 mg tablets) of AstraZeneca Canada Inc., Mississauga, ON L4Y 1M4, in adult participants with carcinoma of the ovary, breast, prostate or adenocarcinoma of the pancreas 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).
- •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 germline BRCA mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
- •Note: Participants 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 platinumbased 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.
- •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 indicate 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.
- •Acceptable hematology status: a.
- •Hemoglobin greater than or equals to 9 g/dL.
- •Absolute neutrophil count (ANC) greater than or equals to 1500 cells/microL.
- •Platelet count greater than or equals to 1,00,000 cells/microL.
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equals to 2.5 x Upper Limit of Normal (ULN) (less than or equals to 5 x ULN for liver metastasis).
- •Aspartate aminotransferase (AST) less than or equals to 2.5 x ULN (less than or equals to 5 x ULN for liver metastasis).
- •Total bilirubin less than or equals to 1.5 x ULN.
- •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 (140 – Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if female x 85 percent.
- •Participant with Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2 (Appendix II).
- •Current non-smokers and non-tobacco users.
- •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 investigational product.
- •Female participant with postmenopausal status (spontaneous amenorrhea for at least 12 consecutive months) OR surgically sterilized OR Female of child bearing potential with a negative pregnancy test must use two acceptable methods of contraception throughout the study period and until 6 months after last dose of investigational product.
- •Participant willing and able to comply with the protocol requirements.
- •Participant 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 who has administered any live vaccine within 28 days prior to randomization.
- •Participant with interstitial pneumonia or symptomatic diffuse 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 doses of steroids before and during study as long as these were started at least 4 weeks prior to treatment.
- •Participant with spinal cord compression.
- •Major surgery within 2 months of screening or not having recovered from any undesirable or harmful effects of any previous 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 (Appendix I).
- •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 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 year prior to screening.
- •Use of dietary items that have effect on Cytochrome P450 enzymes (e.g., pomegranate, star fruit, seville oranges, grapefruit and grapefruit containing products) and PGP (P-Glycoprotein) efflux pump (e.g., St. Johns wort) within 07 days prior to randomization.
- •Participation in any investigational drug study within 30 days prior to screening.
- •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 investigational product.
- •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.
结局指标
主要结局
To evaluate the bioequivalence of Olaparib Tablets 150 mg (2x150 mg tablets)
时间窗: 12 hours (0.071 weeks)
次要结局
- To monitor the safety of the participants.
研究者
Dr Dharmesh Domadia
Cliantha Research Limited
研究点 (14)
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