EUCTR2007-001432-31-NL进行中（未招募）不适用
A Phase 1/2a, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy andPharmacokinetics of BMS-753493 in Subjects with Advanced Cancer. Revised Protocol 02, incorporating Protocol Amendment 02 (Version 1.0, Date 17-Oct-2007) and 03 (Version 1.0, Date 26-Nov-2007). And Pharmacogenetics Blood Sample Amendment 01 (Version 3.0, Date 14-Aug-2007).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Signed Written Informed Consent
- •2) Target population
- •a) Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- •which has progressed on standard therapy or for whom no standard therapy is
- •i) Minimum availability of 10 archived tumor tissue slides, or subject’s
- •willingness and ability to undergo tumor biopsy collection for IHC analysis;
- •either available within 28 days or greater from Cycle 1 Day 1;
- •b) Measurable or non-measurable disease as defined by RECIST criteria;
- •c) Adequate recovery from recent surgery and radiation therapy. At least one week
- •must have elapsed from the time of a minor surgery and at least 3 weeks for major
- •surgery and radiation therapy;
- •d) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see
- •Protocol Appendix 3);
- •e) Available for treatment and follow-up. Subjects enrolled in this trial must be
- •treated at the participating center;
- •f) At least four weeks must have elapsed from the last dose of carboplatin,
- •immunotherapy or chemotherapy, (6 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, etc., 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
- •3) Age and Sex
- •a) Men and women, ages 18 and greater;
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception as per the Investigator’s discretion to avoid pregnancy throughout
- •the study and for up to 4 weeks after the study in such a manner that the risk of
- •pregnancy is minimized.
- •Phase 2 includes the above inclusion criteria and the following:
- •Subjects with measurable, confirmed, advanced ovarian (including primary
- •peritoneal), renal cell or breast cancer or non-measurable, confirmed, advanced
- •ovarian (including primary peritoneal) cancer with CA125 = 2x ULN, which has
- •progressed on standard therapy or for whom no standard therapy is known, in place
- •- Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- •which has progressed on standard therapy or for whom no standard therapy is
- •IHC will be utilized to select subjects prospectively for assignment to the FR+ and
- •FR- groups.
- •For subjects with renal cell cancer, up to 3 prior treatment regimens are permitted,
- •and for subjects with ovarian or breast cancer, up to 4 prior treatment regimens are
- •- If a treatment is stopped and restarted after a disease recurrence, that will be
- •counted as 2 regimens.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Sex and Reproductive Status
- •a)WOCBP unwilling or unable to use an acceptable method to avoid
- •pregnancy for entire study period as per Investigator’s discretion to avoid
- •pregnancy throughout study & for up to 4 weeks after study in such a
- •manner that risk of pregnancy is minimized
- •b)WOCBP using a contraceptive method deemed inappropriate by Investigator
- •c)pregnant or breastfeeding Women
- •d)Women with positive pregnancy test on enrollment or prior to investigational
- •product administration
- •e)Sexually active fertile men not using effective birth control if their partners are
- •2) Medical History and Concurrent Diseases
- •a)Inability to be venipunctured &/or tolerate venous access
- •b)Subjects with known symptomatic brain metastasis. Subjects with controlled brain
- •metastasis will be allowed & steroid therapy may be continued. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI
- •c)CTCAE Grade 2 or greater neuropathy currently or prior history of Grade 3 or greater neuropathy
- •d)Psychiatric disorders or other conditions rendering subject incapable of
- •complying with requirements of protocol
- •e)Serious intercurrent infections, or nonmalignant medical illnesses that are
- •uncontrolled or whose control may be jeopardized by complications of this
- •f)Uncontrolled or significant cardiovascular disease, including:
- •i)myocardial infarction within 6 months
- •ii)uncontrolled angina within 3 months
- •iii)congestive heart failure within 3 months
- •iv)diagnosed or suspected congenital LQT syndrome
- •v)any history of significant arrhythmias (such as ventricular tachycardia,
- •ventricular fibrillation, or torsades de pointes)
- •vi) prolonged QTcF on screening or Cycle 1 Day 1 pre-dose mean (QTcF
- •vii)subjects with pacemaker
- •viii)2nd degree AV block or any form of BBB
- •ix)troponin (T or I)> institutional upper limits of normal
- •x)LVEF< institutional limits of normal as determined by MUGA or
- •echocardiogram
- •xi)inadequate cardiac function as defined by a NYHA classification of >Class I;
- •g)Known MTHFR mutations or known impaired regulation of homocysteine levels;
- •h)Uncontrolled thyroid disorder, including hypothyroidism, hyperthyroidism,
- •Grave’s disease or Hashimoto’s disease. Subjects with hypothyroidism who are
- •on thyroid replacement therapy & whose symptoms of thyroiditis are resolved to
- •=Grade 1 before enrollment are eligible
- •i)Any other sound medical, psychiatric &/or social reason as determined by Investigator
- •3) Physical and Laboratory Test Findings
- •a)Inadequate hematologic function with absolute neutrophils <1,500/mm³, platelets
- •<100,000/mm³ or hemoglobin <10g/dL
- •b)Inadequate hepatic function with serum bilirubin=1.5 x upper institutional limits of normal, ALT = 2.5 x upper institutional limits of normal, AST =2.5 x upper institutional limits of normal
- •c)Inadequate renal function defined as calculated creatinine clearance of <60mL/min according to Cockcroft-Gault formula:
- •i)In men: [eGFRCG(mL/min)]=(140 - age) x weight (kg)/(72 x serum creatinine concentration in mg/dL)
- •ii)In women, multiply this result by 0.85
- •d)Inadequate thyroid function with free T4 &/or TSH outside of institutional limits of normal
- •4) History of any significant drug allergy which in Investigator’s discretion would inhibit subject’s participation
- •5) Prohibited Treatments &/or Therapies
- •a)Exposure to any investigational drug or placebo within 4 weeks of study drug
- 另有 2 项未显示
研究者
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