NL-OMON33965已完成不适用
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subject with Advanced Cancer - CA190-001
Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically or cytologically confirmed diagnosis of solid tumour which has progressed on standard therapy or for whom no standard therapy is known - Minimum of 10 archived tumour tissue slides required, or subject*s willingness and ability to undergo tumour biopsy collection for IHC analysis
- •Measurable or non-measurable disease
- •Men and women, aged 18 or greater
- •ECOG performance status 0*1 (generally fit and mobile)
- •Adequate recovery from recent surgery and radiation therapy - one week for minor surgery and 3 weeks for major surgery and radiation therapy
- •At least four weeks since last dose of carboplatin, immunotherapy or chemotherapy, (six weeks for nitrosoureas, or mitomycin C), prior to beginning protocol therapy. Hormonal anti*cancer agents and nontraditional cytotoxic agents, such as trastuzumab, gefitinib, erlotinib, cetuximab, bevacizumab, are not considered chemotherapy regimens when administered alone, and at least 4 weeks must have elapsed from the last dose of this class of agents before study drug administration.
- •Subjects must have recovered to baseline or Grade 1 from the toxicities resulting from previous therapies.
- •Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout and for 4 weeks after the study.
排除标准
- •Symptomatic brain metastases or sign or symptoms suggestive of them.
- •Current grade 2 motor or sensory Neuropathy or a prior history of grade 3 or greater neuropathy.
- •Uncontrolled or significant cardiovascular disease: Myocardial Infarction within 6 months; uncontrolled angina or conjestive heart failure within 3 months; history of significant arrhythmias; any QT problems;
- •pacemaker; 2nd degree AV block or any form of bundle branch block; troponin (T or I ) above upper limit of normal; left ventricular ejection fraction lower than limit of normal as determined by MUGA or echocardiogram; inadequate cardiac function as defined by a New York Heart Association (NYHA) classification of > Class I
- •Inadequate blood results: haem/hepatic/renal/thyroid function
- •Known methylenetetrahydrofolate reductase (MTHFR) mutations or known impaired regulation of homocysteine levels
- •Uncontrolled thyroid disorder, including hypo and hyper*thyroidism, Grave*s disease or Hashimoto*s disease. Subjects with hypothyroidism who are on thyroid replacement therapy and whose symptoms of thyroiditis are resolved to Grade 1 before enrollment are eligible
- •Inadequate haematological, hepatic, renal or thyroid function.
- •Use of multi*vitamins and/or folic acid supplements for 1 week prior to first day of treatment and throughout the course of the trial
- •Use of steroids except for anti*emetic purposes and/or continuing therapy for controlled brain metastases, chronic steroid use if required for disease, appetite stimulation, treatment of hypersensitivity reactions and for prevention of same, premedication prior to CT scan requiring IV contrast in subjects with IV contrast allergy
- •Use of known P-glycoprotein inhibitors for 1 week prior to first day of treatment and throughout the course of the trial
- •Inability to provide an archived tumour sample (10 slides) for analysis within 28 days of study drug Administration
- •Women of child-bearing potential who are unwilling or unable to use an acceptable method of contraception.
- •Sexually active fertile men not using effective birth control if their partners are of child-bearing potential.
- •Women who are pregnant or breastfeeding.
- •Exposure to any investigational drug or placebo within 4 weeks of study drug administration.
- •Other concurrent anti-cancer therapy
- •Prior radiation including more than 25% of major bone marrow containing areas
研究者
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