EUCTR2007-001433-34-GB进行中（未招募）不适用
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy andPharmacokinetics of BMS-753493 in Subjects with Advanced Cancer.Revised Protocol 04, incorporating Protocol Amendment 02 (v1.0, Date 16-Oct-2007), 03 (v1.0, Date 26-Nov-2007), 04 (v2.0, Date 20-May-2008), and 05 (v3.0, date 24-Mar-2009). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (version 2.0, Date 16-Jul-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
- •a) The signed informed consent form.
- •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 known;
- •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, (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
- •3) Age and Sex
- •a) Men and women, ages 18 and greater;
- •Phase 2 includes the above inclusion criteria and the following:
- •Subjects with measurable, confirmed, advanced ovarian (including primary peritoneal or fallopian tube), renal cell or breast cancer or non-measurable, confirmed, advanced ovarian (including primary peritoneal or fallopian tube) cancer with CA125 = 2x ULN, which has progressed on standard therapy or for whom no standard therapy is known, in place of:
- •- Histologically or cytologically confirmed diagnosis of solid tumor malignancy which has progressed on standard therapy or for whom no standard therapy is known.
- •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 cancer up to 4 prior treatment regimens are permitted. For subjects with breast cancer, up to 4 prior cytotoxic treatment regimens, with no more than 3 in the advanced disease setting, are permitted. Hormonal therapies are not included in these counts of previous treatment regimens.
- •- 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 who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period 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.
- •b) WOCBP using a contraceptive method deemed inappropriate by the Investigator.
- •c) Women who are pregnant or breastfeeding
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period 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.
- •b) WOCBP using a contraceptive method deemed inappropriate by the Investigator.
- •c) Women who are pregnant or breastfeeding
- •on thyroid replacement therapy and whose symptoms of thyroiditis are resolved to
- •= Grade 1 before enrollment are eligible;
- •i) Any other sound medical, psychiatric and/or social reason as determined by the
- •Investigator.
- •3) Physical and Laboratory Test Findings
- •a) Inadequate hematologic function with absolute neutrophils <1,500/mm3, platelets
- •<100,000/mm3, or hemoglobin <10 g/dL;
- •b) Inadequate hepatic function with serum bilirubin =1.5 times the upper
- •institutional limits of normal, ALT = 2.5 times the upper institutional limits of
- •normal, AST = 2.5 times the upper institutional limits of normal;
- •c) Inadequate renal function defined as a calculated creatinine clearance of < 60
- •mL/min according to the 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 and/or TSH outside of the institutional
- •limits of normal unless approved by Medical Monitor.
- •4) Allergies and Adverse Drug Reactions
- •a) History of any significant drug allergy which in the Investigator’s discretion
- •would inhibit the subject’s participation.
- •5) Prohibited Treatments and/or Therapies
- •a) Exposure to any investigational drug or placebo within 4 weeks of study drug
- •administration;
- •b) Use of multi-vitamins and/or folic acid supplements for 1 week prior to Cycle 1
- •Day 1 and throughout the course of the trial;
- •c) Other concurrent chemotherapy hormonal therapy, immunotherapy regimens or
- •radiation therapy, standard or investigational;
- •d) Prior radiation must not have included =25% of major bone marrow containing
- •areas (pelvis, lumbar spine);
- •e) Use of steroids except in the following instances, in which the use of steroids is allowed:
- •for anti-emetic purposes.
- •continuing therapy for controlled brain metastases.
- •chronic steroid use in the context of a disease requiring such use .
- •for appetite stimulation.
- •Treatment of a hypersensitivity reaction and as subsequent premedication for the
- •prevention of same
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