NCT00058539已完成2 期
A Phase II, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Omnitarg (Pertuzumab) in Subjects With Castration-Resistant Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age >= 18 years old
- •Histologically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone [LHRH] agonist). Subjects must have documented progression following hormonal therapy withdrawal of >= 4 weeks duration; nilutamide and bicalutamide require 6 weeks withdrawal.
- •Progression of disease after one prior chemotherapy regimen (which must have been taxane-based) for CRPC. Progression is defined as at least one of the following: A minimum of three consecutive serum PSA measurements obtained >= 14 days apart and all within 3 months, with progressively increasing values for two consecutive measurements. The latest value must be obtained within the screening period and must be >= 5 ng/mL; or progression of measurable disease, as defined by RECIST; or progression of bone disease, as defined by the appearance of one or more new bone lesions
- •Orchiectomy, or castrate levels of testosterone maintained by LHRH agonist <70 ng/mL
- •Life expectancy >= 12 weeks
- •ECOG performance status of 0 or 1
- •Granulocyte count of >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin of >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp] is permitted)
- •Serum bilirubin less than or equal to the upper limit of normal (ULN), unless due to Gilbert's disease, and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases)
- •Serum creatinine <= 1.5 x ULN
- •International normalized ratio (INR) <1.5 and activated partial thromboplastin time (aPTT) <1.5 x ULN (except for subjects receiving warfarin)
- •Willing to complete serial PROSQOLI/PPI evaluations and serial diaries of analgesic use (if necessary)
排除标准
- •Prior chemotherapy, radiotherapy, therapeutic radionucleotide or immunotherapy within 4 weeks of Day 1 (the day of the first rhuMAb 2C4 dose). Flutamide therapy, or other second line hormonal therapies should be withdrawn >= 4 weeks prior to Day
- •Bicalutamide and nilutamide therapy should be withdrawn >= 6 weeks prior to starting study medication.
- •Prior treatment with HER2 pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, and TAK165)
- •Treatment with other experimental anticancer agents within 4 weeks prior to Day 1
- •Prior history or clinical evidence of central nervous system or brain metastases
- •Ejection fraction, determined by ECHO, <50%
- •Uncontrolled hypercalcemia (>11.5 mg/dL)
- •Prior exposure of >360 mg/m2 doxorubicin, >120 mg/m2 mitoxantrone, or >90 mg/m2 idarubicin
- •Ongoing corticosteroid treatment, except for subjects who are on stable doses of <20 mg of prednisone daily (or equivalent), or who are taking corticosteroids for reasons unrelated to prostate cancer
- •History of other malignancies within 5 years prior to Day 1, except for adequately treated basal or squamous cell skin cancer
- •History of serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure >100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible)
- •Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Known human immunodeficiency virus infection
- •Major surgery or significant traumatic injury within 3 weeks prior to Day 1
- •Inability to comply with study and follow-up procedures
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk for treatment complications
结局指标
主要结局
Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
时间窗: Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab
Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.
Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months
时间窗: 3 months
Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.
次要结局
- Duration of Response(Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab)
- Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])(Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab)
- Median Time of PFS(Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab)
- Percentage of Participants Who Progressed at 3, 6 and 9 Months(3, 6, and 9 months)
- Serum Concentrations of Pertuzumab(Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36)
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