CTRI/2019/05/019051暂停未知
A Pivotal Pharmacokinetic Bioequivalence Study Comparing Generic to Reference Liposome-Encapsulated Doxorubicin Hydrochloride in Subjects with Metastatic Breast Cancer and/or with Advanced Ovarian Carcinoma Who Have Failed Platinum-Based Chemotherapy - TOL2718
Aine Cunningham0 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
- 未知
- 状态
- 暂停
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Female between 18 and 75 years of age, inclusive.
- •2. Patients with documented advanced ovarian cancer who have failed a first-line platinum-based chemotherapy regimen OR
- •3. Patients with documented metastatic breast cancer
- •4. Having a Body Mass Index (BMI) of at least 17.00 kg/m2
- •5. Able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial.
- •6. Recovery from any toxic effects of previous chemotherapy as judged by the Investigator.
- •7. Able and clinically indicated to receive liposomal formulation of doxorubicin HCl, as specified in the Caelyx Summary of Product Characteristics (SmPC), without exceeding a lifetime cumulative anthracycline dosage of 450 mg/m2 (See for rationale). Prior use of conventional or liposomal doxorubicin formulations, in addition to the use of other anthracyclines/anthracenediones or 5-fluorouracil, should be included in calculations of total lifetime cumulative dose.
- •8. Able and clinically indicated to receive the recommended minimum 4 courses of a liposomal formulation of doxorubicin HCl either during participation in this study, including infusions prior to enrolling in this study or after completing study participation
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. Any subject who experiences deterioration in ECOG status to 4 during the study should discontinue participation in the study.
- •10. Life expectancy of > 180 days.
- •11. Acceptable hematology status:
- •a. Hemoglobin >= 9 g/dL
- •b. Absolute neutrophil count (ANC) >= 1500 cells/μL
- •c. Platelet count >= 75,000 cells/μL
- •12. Acceptable liver function:
- •a. Alanine aminotransferase (ALT) <= 2X upper limit of normal (ULN)
- •b. Aspartate aminotransferase (AST) <= 2X ULN
- •c. Bilirubin < 1.2 mg/dL
- •d. Alkaline phosphatase <= 2X ULN
- •13. Acceptable kidney function
- •a. Creatinine <= 2X ULN
- •b. Creatinine clearance >= 60 mL/minute
- •14. Cardiac ejection fraction >= 50% by echocardiogram (ECHO) within 14 days prior to first dose of Investigational Product.
- •15. For subjects of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 0 and Cycle 2 Day 0
- •16. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •17. All female subjects who are sexually active with a male partner must be willing to use 1 of the following acceptable contraceptive methods throughout the study and for 6 months immediately following the last dose of IP (TEST or RMP):
- •a. Intrauterine device
- •b. Double barrier methods (e.g., condom or diaphragm with intra-vaginally applied spermicide)
- •c. Prescription hormonal contraceptives
- •d. Sterile male partner (vasectomized >= 6 months prior to IP dosing)
排除标准
- •1. Received a liposomal formulation of doxorubicin HCl in the past and had a required dose reduction to below 50 mg/m2, or whose disease has progressed or recurred after treatment with a liposomal formulation of doxorubicin HCl.
- •2. Prior dose limiting toxicity on pegylated liposomal doxorubicin HCl at 50 mg/m2
- •3. Prior radiation therapy within the 14 days prior to first dosing of IP.
- •4. Use of steroids and/or anti-convulsive agents within three months prior to screening (for patients with previously diagnosed brain metastases).
- •5. Recent (6 month) history of impaired cardiac function and any of
- •the following conditions (See Caelyx SmPC â?? based on Investigator discretion):
- •Unstable angina
- •Significant ECG abnormalities
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Myocardial infarction
- •New York Heart Association (NYHA) class III-IV heart failure
- •Liver disease
- •Kidney disease
- •Clinically significant pericardial disease
- •Electrocardiographic evidence of acute ischemic or active conduction system 1. Received a liposomal formulation of doxorubicin HCl in the past and had a required dose reduction to below 50 mg/m2, or whose disease has progressed or recurred after treatment with a liposomal formulation of doxorubicin HCl.
- •2. Prior dose limiting toxicity on pegylated liposomal doxorubicin HCl at 50 mg/m2
- •3. Prior radiation therapy within the 14 days prior to first dosing of IP.
- •4. Use of steroids and/or anti-convulsive agents within three months prior to screening (for patients with previously diagnosed brain metastases).
- •5. Recent (6 month) history of impaired cardiac function and any of
- •the following conditions (See Caelyx SmPC â?? based on Investigator discretion):
- •Unstable angina
- •Significant ECG abnormalities
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Myocardial infarction
- •New York Heart Association (NYHA) class III-IV heart failure
- •Liver disease
- •Kidney disease
- •Clinically significant pericardial disease
- •Electrocardiographic evidence of acute ischemic or active conduction system 1. Received a liposomal formulation of doxorubicin HCl in the past and had a required dose reduction to below 50 mg/m2, or whose disease has progressed or recurred after treatment with a liposomal formulation of doxorubicin HCl.
- •2. Prior dose limiting toxicity on pegylated liposomal doxorubicin HCl at 50 mg/m2
- •3. Prior radiation therapy within the 14 days prior to first dosing of IP.
- •4. Use of steroids and/or anti-convulsive agents within three months prior to screening (for patients with previously diagnosed brain metastases).
- •5. Recent (6 month) history of impaired cardiac function and any of
- •the following conditions (See Caelyx SmPC â?? based on Investigator discretion):
- •Unstable angina
- •Significant ECG abnormalities
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Myocardial infarction
- •New York Heart Association (NYHA) class III-IV heart failure
- •Liver disease
- •Kidney disease
- •Clinically significant pericardial disea
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