EUCTR2009-009894-88-DE进行中（未招募）1 期
apatinib versus Lapatinib with Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A randomized phase II trial - Gastro-Lap
niversity Hospital of Heidelberg0 个研究点目标入组 76 人开始时间: 2009年6月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
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
入选标准
- •Histologically confirmed adenocarcinoma of the stomach, including adenocarcinoma of the gastroesophageal junction and esophagus
- •Metastatic disease
- •Measurable disease (according to RECIST criteria)
- •At least one prior chemotherapy for metastatic disease with progression during or no later than 6 months after last administration of chemotherapy. Chemotherapy must have con¬tained a platinum compound (cisplatin or oxaliplatin)
- •Her2 overexpression measured by FISH (amplification or increased gene copy number). Immunohistochemistry (ICH) 3+ can be included in case of an uncertain FISH test.
- •Patient willing to allow for biomarker analyses on his tumor tissue.
- •Written informed consent given prior to any protocol specific procedures according to the local regulatory requirements
- •Age >= 18 years
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) = 2
- •Life expectancy > 3 months
- •Adequate hematological, hepatic and renal function defined by:
- •Hematology: Neutrophils >1.5x109/L; Platelets >100x109/L; Hemoglobin >8g/dL
- •Hepatic function: Total bilirubin <=1.5xULN; ASAT (SGOT) and ALAT (SGPT) <= 2.5xULN; Alkaline phosphatase <5xULN.
- •Renal function: The calculated creatinine clearance should be =60 mL/min
- •Eligibility of patients receiving medications or substances known to affect, or with the poten¬tial to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the local Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in: Cytochrome P-450 Enzymes and Drug metabolism. In: Lacy CF, Armstrong LL, Goldman MP, Lance LL eds. Drug Information Handbook 8TH ed. Hudson, OH; LexiComp Inc. 2000: 1364-1371
- •Able to swallow and retain oral medication
- •Negative pregnancy test (urine or serum) within 28 days prior to randomization for all women of childbearing potential (has to be verified within 7 days prior to randomization and during the study according the judgement of the investigator)
- •Willingness to perform double-barrier contraception during study and 6 months after end of treatment
- •Ability to understand and the willingness to sign a written informed consent document
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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
- •Previous non curatively treated malignant disease other than the current gastroesophageal cancer with a disease-free survival of less than 5 years
- •History of significant neurological or psychiatric disorders including psychotic disorders, de¬mentia or seizures that would prohibit the understanding and giving of informed consent
- •History of active Hepatitis B or C or history of an HIV infection
- •Active uncontrolled infection
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to randomisation.
- •Concurrent treatment with any other anti-cancer drug.
- •Presence of other medication that may interfere with study treatment or the action of the investi¬gational product or confuse the assessment of study results
- •History of allergic reactions attributed to compounds of similar chemical or biologic composi¬tion to lapatinib or to any excipients
- •History of allergic reactions attributed to compounds of similar chemical composition to cape¬citabine, fluorouracil or to any excipients
- •Known DPD deficiency
- •Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
- •Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Active cardiac disease, defined as:
- •History of uncontrolled or symptomatic angina
- •History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
- •Myocardial infarction < 6 months from randomization
- •Uncontrolled or symptomatic congestive heart failure (> New York Heart Association score 2)
- •Ejection fraction below the institutional normal limit
- •Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- •Pregnancy and lactation
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investiga¬tional medicinal product
- •Participation in another clinical trial.
研究者
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