A phase II/III Open label Multicentric Randomized trial to determine the safety and efficacy of Non-pegylated Liposomal Doxorubicin (Nudoxa) at two different dose levels as compared to doxorubicin in patients with metastatic breast cancer.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 16
- 主要终点
- In Part A: The primary objective of this study is to compare the overall response rate (ORR) to 60 or 70 mg/m2 of NPLD in target lesions of MBC using RECIST criteria.
研究概览
简要总结
This is a phase II/III Open label Multicentric Randomized trial to determine the safety and efficacy of Non-pegylated Liposomal Doxorubicin (Nudoxa) at two different dose levels (60 mg/m2 or 70 mg/m2 ) NPLD as compared to doxorubicin in patients with metastatic breast cancer.
In Part A, 12 subjects will be allotted to 60 mg/m2 or 70 mg/m2 NPLD and followed upto 8th cycle for efficacy and safety and on completion of Part A, part B study will be started. The optimal selected regimen will be studied in up to 70 patients. The sample size for part B will be decided after reviewing the safety and efficacy of two regimens in MBC.
The primary objectives in Part A will be to determine the overall response rate to NPLD (60 and 70 mg/m2) in target lesions of MBC using RECIST criteria and in Part B will be to determine the overall response rate to selected dose of NPLD as compared to doxorubicin 70 mg/m2 in target lesions of MBC using RECIST criteria.
The secondary objectives in Part A will be to evaluate the overall response rate to NPLD (60mg/m2 and 70 mg/m2) in non-target lesions of MBC using the RECIST criteria and in part B will be to evaluate the overall response rate to selected dose of NPLD as compared to 70 mg/m2 doxorubicin in non target lesions of MBC using the RECIST criteria. Also the frequency and severity of adverse events (AEs) for all patients enrolled will be dtermined. The evaluation of primary and secondary variables will be done at screening and on Day 1+/- 3 days of every alternate cycle beginning with cycle 3 and at the end of the study (visit 1, 4, 6, 8 and 10)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects aged 18 years.
- •Life expectancy of atleast 6 months at the time of enrolment.
- •Histologically confirmed metastatic breast cancer with at least one measurable lesion as determined by RECIST criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •No other malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery).
- •Baseline left ventricular ejection fraction (LVEF) more than 50 % as determined by 2D ECHO.
- •Subjects who have not been previously treated for advanced metastatic disease.
- •Prior adjuvant and neo-adjuvant chemotherapy is allowed if 1 year has elapsed since discontinuation of treatment.
- •If previously treated with doxorubicin and/or epirubicin in past, total lifetime exposure shall not be more than 300mg/m2 of doxorubicin or 450 mg/m2 of epirubicin.
- •Sufficient hepatic, renal and bone marrow function (Patients with elevated bilirubin and / or elevated ALT/AST will be eligible for inclusion, if reduced liver function was secondary to liver metastasis).
- •Serum bilirubin less than / equal to 1.5 x the upper limit of normal (ULN) b.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than / equal to 3 x ULN, except in the presence of hepatic metastases, where less than / equal to 5 x ULN is allowed.
- •Serum Creatinine less than / equal to 1.5 times the ULN.
- •Absolute neutrophil count greater than / equal to 1.5 x 109/L e.
- •Platelet count greater than / equal to 100 x 109/L f.
- •Haemoglobin greater than / equal to 9 g/dL 11) Patient ensuring geographical accessibility to the participating oncology centre and compliance with treatment and scheduled follow-up.
- •If the subject is of childbearing potential, she must have a negative pregnancy test at screening.
- •(Women with childbearing potential will be advised to take adequate precautions to prevent pregnancy) 13) Subject or her legal representative has signed the informed consent.
排除标准
- •Pregnancy or breast-feeding.
- •Woman with childbearing potential with inadequate protection against pregnancy.
- •Any other uncontrolled illness.
- •Other conditions such as benign breast cancer and malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery); 5) Subject treated for advanced breast cancer in past one year.
- •Presence of active infections.
- •Presence of cerebral metastases.
- •Clinically insufficient renal, hepatic and bone marrow function.
- •Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia.
- •Early breast cancer with non-measurable lesion, rising of tumour markers, lymphangitic neoplasm or sclerosing bone lesions as the only sign of disease.
- •Patient with known or suspected Allergy to the Investigational product, other Anthracyclines, egg or egg products or any agent given in association with this trial.
- •Patients who have participated in another clinical trial study during the past 30 days or who are likely to simultaneously participate in another clinical study.
结局指标
主要结局
In Part A: The primary objective of this study is to compare the overall response rate (ORR) to 60 or 70 mg/m2 of NPLD in target lesions of MBC using RECIST criteria.
时间窗: The evaluation will be done on visit 1, 4, 6, 8 and 10
In Part B: The primary objective of this study is to assess the overall response rate (ORR) to NPLD (70 mg/m2)(NUDOXA)in target lesions of MBC using RECIST criteria.
时间窗: The evaluation will be done on visit 1, 4, 6, 8 and 10
次要结局
- Part A:The secondary objectives are to evaluate the overall response rate to NPLD (60 and 70mg/m2) in non-target lesions of MBC using RECIST criteria.Part B:To evaluate the overall response rate to NPLD(70mg/m2) as compared to doxorubicin 70 mg/m2 in non-target lesions of MBC using the RECIST criteria.(The evaluation will be done on visit 1, 4, 6, 8 and 10 for secondary objectives.)