CTRI/2023/04/051731招募中Unknown
A Randomized, Open-Label, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multicenter, Multiple-Dose, Fully Replicate, Steady State Bioequivalence Study of Olaparib Tablets 150 mg of Zydus Lifesciences Limited and Lynparza® (Olaparib) Tablets 150 mg of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 in Adult Subjects with Cancer and Stable on Olaparib Therapy under Fasting Condition.
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive).
- •2. Subject with deleterious or suspected deleterious germline or somatic BRCA mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy OR Subject with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy OR Subject 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 Subject with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting Subject with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy OR Subject with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen OR Subject 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.
- •3. Subject with body mass index (BMI) 18-30 kg/m2 (both inclusive).
- •4. Subject stabilized on Olaparib tablet therapy (Dose: 600 mg/day).
- •5. Adequate organ and marrow function:
- •a. Hemoglobin = 10 g/dL with no blood transfusions in the previous 28 days prior to randomization
- •b. Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •c. White blood cells (WBC) >3 x 109/L
- •d. Platelets = 100 x 109/L
- •e. Total bilirubin = 1.5 x Upper Limit Normal (ULN)
- •f. AST/ ALT = 2.5 x ULN, if liver metastases then = 5 x ULN
- •g. Serum creatinine = 1.5 x ULN
- •6. Calculated serum creatinine clearance > 50 mL/min (using Cockroft-Gault formula) which is as follows:
- •Formula of creatinine clearance: Crcl equals to (140 minus Age) x mass (Kilogram weight) percentage 72 x SCr in (mg/dl) if ‘female’ x 85 percentage.
- •7. Eastern Cooperative Oncology Group (ECOG) 0-1.
- •8. Life expectancy = 16 weeks.
- •9. Male subject with confirmed diagnosis of metastatic castration-resistant prostate cancer must had bilateral orchiectomy.
- •10. Male subject 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.
- •11. 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:
- •a. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.
- •b. 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL.
- •c. Radiation-induced oophorectomy with last
排除标准
- •Subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Subject with a known hypersensitivity to olaparib or any of the excipients of the product.
- •2. Subject having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue).
- •3. Subject who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to enrollment on study.
- •4. Subject unable to swallow orally administered medication and subject with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •5. Subject receiving any systemic chemotherapy, radiotherapy within 4 weeks prior to study treatment.
- •6. Concomitant use of known potent CYP3A4 (Cytochrome P4503A4) inhibitors or inducer.
- •7. Subject with any ongoing toxicities (CTCAE (Common Terminology Criteria for Adverse Events) = grade 2), with the exception of alopecia, caused by previous cancer therapy.
- •8. QTc (Heart Rate Corrected QT interval) > 470 msec or family history of long QT syndrome. QT interval will be calculated with Bazett’s Formula.
- •9. Subject with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- •10. Subject with myelodysplastic syndrome/acute myeloid leukemia.
- •11. Subject with history/ risk of venous thromboembolic events.
- •12. Subject with symptomatic uncontrolled brain metastases Subject can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment and Subject with cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- •13. Major surgery within 2 months of study starting and subject must have recovered from any undesirable or harmful effects of any major surgery.
- •14. Subject with known serum positivity for Hepatitis B, C or HIV.
- •15. Consumption of any grapefruit, star fruit, grape fruit juice, seville oranges, and seville orange juice and its products within 07 days prior to first dosing of Period I.
- •16. Ingestion of any alcoholic food (e.g. plum pudding, cake, chocolate containing alcohol) or beverage containing alcohol or utilize recreational drugs, caffeine or xanthine containing food or beverage within the 48 hours prior to randomization.
- •17. History of drug dependence, history of alcoholism in the past 2 years prior to screening.
- •18. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
- •19. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
- •20. History of allergic response to heparin.
- •21. 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.
- •22. Participation in any investigational drug study within 30 days prior to screening.
- •23. Institutionalized subject.
- •24. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject’s participation in this study.
- •25. Any other condition that, in the investigator’s judgment, might increase the risk to the subject or
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