Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy
研究概览
简要总结
The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
详细描述
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive carfilzomib 2 days a week for the first 3 weeks of each 4-week study cycle (Days 1, 2, 8, 9, 15, and 16 of each cycle). Each dose is given by vein over about 30 minutes.
Before you receive the study drug, you will be given dexamethasone to help decrease the risk of side effects during the first cycle. You may ask the study staff for information about how the drugs are given and their risks.
During Cycle 1, you will receive extra fluid (saline) by vein before each dose of study drug. This is part of standard clinical care. This will also be done during Cycle 2, if the study doctor thinks it is needed.
You will remain in the clinic for an extra hour after receiving each dose during Cycle 1 and after the first dose of Cycle 2, to receive additional fluids by vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven clear cell kidney cancer with metastatic disease. Progressive disease or intolerance to at least one but not more than three (3) prior systemic therapy(ies)
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
- •Age >/= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate hepatic function with serum ALT and AST </= 3.0 times the upper limit of normal and serum direct and total bilirubin </= 1.5 times the upper limit of normal.
- •Absolute neutrophil count (ANC) >/= 1.0 × 10^9/L; patients with an ECOG performance status of 2 at study entry must have an ANC >/= 1.5 x 10^9/L
- •Hemoglobin >/= 8 g/dL (80 g/L) within 14 days prior to beginning study treatment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines); Patients with an ECOG performance status of 2 at study entry must have a hemoglobin >/= 9 g/dL (transfusion assistance acceptable)
- •Platelet count >/= 50 × 10^9/L; Patients with an ECOG performance status of 2 at study entry must have a platelet count >/= 100 × 10^9/L
- •Creatinine clearance (CrCl) >/= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- •Written informed consent in accordance with federal, local, and institutional guidelines.
- •Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
- •Male subjects must agree to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
排除标准
- •Brain metastases not controlled with surgery, whole brain radiotherapy, or with stereotactic radiosurgery
- •Systemic therapy within two weeks of treatment initiation
- •Pregnant or lactating females
- •Major surgery within 21 days prior to beginning study treatment
- •Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to beginning study treatment
- •Known human immunodeficiency virus infection
- •Active hepatitis B or C infection
- •Unstable angina or myocardial infarction within 4 months prior to beginning study treatment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- •Uncontrolled hypertension (defined by BP consistently > 150/100) or uncontrolled diabetes (defined by HbA1c > 8.5) within 14 days prior to beginning study treatment
- •Nonhematologic malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- •Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to beginning study treatment
- •Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to beginning study treatment
- •Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
研究组 & 干预措施
Carfilzomib
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
干预措施: Carfilzomib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy
时间窗: The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months
Progression free survival defined as time from enrollment to progression or death, whichever comes first. Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.
次要结局
- Overall Response Rate (ORR)(Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months)
- Overall Survival (OS)(15 months)
- Safety of Carfilzomib(4 months)
- PFS and ORR as a Function of VHL Mutation Subtype(No data collected)