EUCTR2006-000914-19-GR进行中（未招募）不适用
A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.
Johnson & Johnson Pharmaceutical Research & Development0 个研究点目标入组 500 人开始时间: 2006年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •Men or women, 18 years of age or older
- •Any histologically confirmed nonmyeloid tumor at initial diagnosis
- •Day 1 baseline Hb d11 g/dL
- •Expected to receive at least 12 weeks of chemotherapy after enrollment
- •into the study. For subjects receiving cyclic chemotherapy,
- •randomization must be on the first day of a chemotherapy cycle. For
- •subjects receiving non-cyclic chemotherapy, randomization may occur at
- •any time during the chemotherapy.
- •ECOG performance status d2 (Attachment 3)
- •Life expectancy of >6 months, based on the clinical judgment of the
- •investigator
- •Normal neutrophil count (>1.5 x 109/L) at start of initial chemotherapy
- •Normal platelet count (>100 x 109/L) at start of initial chemotherapy
- •Serum creatinine and bilirubin <1.5 times the upper limit of normal
- •(ULN); aspartate aminotransferase (AST), alanine aminotransferase
- •(ALT), alkaline phosphatase <3 times the ULN
- •Female subjects must be postmenopausal (for at least 1 year), surgically
- •sterile, abstinent, or, if sexually active, be practicing an effective method
- •of birth control (e.g., prescription oral contraceptives, contraceptive
- •injections, intrauterine device, double-barrier method, contraceptive
- •patch, male partner sterilization) before randomization; have a negative
- •serum beta-human chorionic gonadotropin (²-hCG) pregnancy test
- •within 2 weeks before randomization; and a negative urine pregnancy
- •test at randomization.
- •Subjects (or their legally acceptable representatives) must have signed
- •an informed consent document indicating that they understand the
- •purpose of and procedures required for the study and are willing to
- •participate in the study.
- •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
- •History of active second cancer except for adequately treated skin cancer
- •and in situ cervical cancer
- •History of DVT or PE within 12 months before study entry or at any
- •time if the event is related to the current cancer, which is defined as
- •diagnosis of the cancer within 3 months of a DVT/PE episode or a
- •DVT/PE following the cancer diagnosis/treatment. Prior superficial
- •thrombophlebitis is not an exclusion criterion.
- •History of CVA, TIA, ACS, or other arterial thrombosis within 6 months
- •before study entry. ACS includes unstable angina, QwMI, and NQMI
- •Onset of seizures within 3 months before randomization or poorly
- •controlled seizures
- •Brain tumor or brain metastasis from another malignancy
- •Evidence of ischemic heart disease, New York Heart Association
- •(NYHA) Class 3 to 4 cardiac disease (Attachment 4) or significant
- •arrhythmias
- •Uncontrolled hypertension (systolic >180 mmHg, diastolic >100 mmHg)
- •while receiving antihypertensive therapy or not on therapy
- •Anemia secondary to vitamin B12, folic acid, or iron deficiency
- •Anemia known to be secondary to gastrointestinal bleed, hemolysis
- •(acquired or hereditary, e.g., sickle cell syndrome, thalassemia
- •syndrome), PRCA, or primary myelodysplastic syndrome
- •Presence of other comorbid conditions or illnesses of the cardiovascular,
- •respiratory, renal, or other body systems that would preclude
- •administration of planned chemotherapy
- •Previous therapy with any marketed epoetin product within 2 months
- •before randomization, lack of response to prior therapy with any epoetin
- •product, or use of any investigational epoetin product at any time
- •Major surgery within 4 weeks before randomization or any preplanned
- •surgery during the study
- •Current treatment with therapeutic or prophylactic anticoagulants. The
- •only exceptions are low dose aspirin (d325 mg/d) in subjects with
- •known cardiovascular disease or low dose anticoagulants to maintain
- •patency of intravenous lines
- •Planned myeloablative chemotherapy with stem cell rescue or bone
- •marrow transplant
- •Have received an experimental drug or used an experimental medical
- •device within 3 months before the planned start of treatment.
- •Is pregnant or breast-feeding
- •Known hypersensitivity to epoetin alfa, or mammalian-cell derived
- •products or formulation excipients
- •Employees of the investigator or study center, with direct involvement in
- •the proposed study or other studies under the direction of that
- •investigator or study center, as well as family members of the employees
- •or the investigator.
研究者
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