ACTRN12613000063718进行中（未招募）2 期
Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine KinaseInhibitors. Hoosier Oncology Group GU09-145
Bionomics Pty Ltd0 个研究点目标入组 134 人开始时间: 2013年1月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Written informed consent and HIPAA authorization for release of personal
- •health information.
- •NOTE: HIPAA authorization may be included in the informed consent orobtained separately.
- •Age > or equal to 18 years at the time of consent.
- •Karnofsky Performance Score (KPS) > or equal to 70 within 7 days prior to registration for protocol therapy.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test
- •within 7 days prior to registration for protocol therapy. NOTE:
- •Females are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal
- •ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Females must not be breastfeeding.
- •Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma). NOTE: No component of collecting duct or medullary histology is allowed. Up to 30% sarcomatoid histology will be permitted.
- •Metastatic or locally advanced unresectable RCC. NOTE: Prior
- •nephrectomy is not mandatory
- •Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors
- •(TKIs). NOTE: Patients who did not tolerate a VEGF-directed TKI may also be considered for entry to the trial. The Sponsor is to be consulted in such cases.
- •Prior treatment with more than 2 VEGF-directed TKIs will be permitted
- •in the phase I component of the study.
- •Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- •Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen.
- •At least 30 days must have elapsed prior to registration following major
- •surgery (opening of a body cavity – chest, abdomen or cranium), or at least 7 days prior to registration for minor surgery.
- •Prior radiation therapy to <25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if
- •completed within 14 days prior to registration for protocol therapy.
- •Corrected QT interval (QTc) < or equal to 450 msec within 7 days prior to registration
- •for protocol therapy. NOTE: if (QTc) is >450 and < or equal to 500 msec, subject to local cardiology review and approval, the patient may be enrolled if the QTc elevation is deemed clinically insignificant.
- •NOTE: Laboratory values must be obtained within 7 days prior to
- •registration for protocol therapy.
- •White blood cell count (WBC) >or equal to 3.5 K/ mm3
- •Hemoglobin (Hgb) > or equal to 8.5 g/dL
- •Platelets > or equal to 100 K/ mm3
- •Absolute neutrophil count (ANC) > or equal to 1.5 K/ mm3
- •Serum Creatinine <2.5 x ULN (upper limit normal)
- •Total Bilirubin < and equal to 1.25 x ULN
- •Aminotransferase (AST and ALT) < or equal to 2.5 × ULN
排除标准
- •No clinically significant infections as judged by the treating investigator
- •No liver disease such as cirrhosis, chronic active hepatitis or chronic
- •persistent hepatitis
- •No prior treatment with temsirolimus or everolimus in the phase II component of the study NOTE: Prior treatment with these agents is permitted in the phase I component of the study. In those cases where everolimus is being used immediately prior to study entry, a washout period will not be required.
- •No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
- •NOTE: Low dose warfarin for catheter prophylaxis or acetylsalicylic acid < equal to 325 mg/day is acceptable.
- •No uncontrolled hypertension, BP >150/100mmHg despite use of antihypertensive medication(s).
- •No thrombotic event within 6 months (deep vein thrombosis, pulmonary
- •embolism) of registration for protocol therapy.
- •No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
- •No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30
- •days prior to registration for protocol therapy.
- •No grade 2 or greater peripheral neuropathy.
- •No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy.
- •NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis > or equal to 30 days prior to registration for
- •protocol therapy, are off steroids, and are asymptomatic.
- •No other currently active malignancy.
- •No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration patients AE must be resolved back to baseline.
研究者
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