EUCTR2008-005448-18-ES进行中（未招募）1 期
Ensayo clínico abierto de MORAb-009 en combinación con pemetrexed y cisplatino en pacientes con mesotelioma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
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
- •1.Female or male and ? 18 years of age.
- •2.Life expectancy of at least 3 months.
- •3.Histologically confirmed unresectable MPM (epithelial or mixed subtypes of at least 75% epithelial content).
- •4.Measurable disease at Screening.
- •5.Karnofsky performance status of ? 70% at Screening (Appendix 3).
- •6.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1.
- •7.Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
- •Absolute neutrophil count (ANC)? 1.5 x 109/L
- •Platelet count? 100 x 109/L
- •Hemoglobin? 9 g/dL
- •Serum bilirubin? 1.5 x upper limit of normal (ULN)
- •Aspartate transaminase (AST)*? 2.5 x ULN
- •Alanine transaminase (ALT)*? 2.5 x ULN
- •Alkaline phosphatase (ALK-P)*? 3 x ULN
- •Serum creatinine? 2.0 mg/dL
- •* Subjects with liver function abnormalities greater than the ULN specified above are eligible only if, in the opinion of the investigator, they are due to disease obstruction of the bile ducts or metastatic disease. Stenting to reduce liver functions to qualifying levels is permitted.
- •8.Calculated serum creatinine clearance ? 60 mL/min using the Cockroft Gault equation (Appendix 7).
- •9.Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
- •10.Willing and able to provide written informed consent.
- •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.Sarcomatous subtype of mesothelioma.
- •2.Prior systemic therapy or radiotherapy for mesothelioma; prior treatment with local radiotherapy for symptom control (ie, non-curative intent) is permitted.
- •3.Known central nervous system (CNS) tumor involvement.
- •4.Evidence of other active malignancy requiring treatment.
- •5.Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
- •6.Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
- •7.Clinically significant arrhythmias demonstrated on electrocardiogram (ECG) (Note: Subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
- •8.Active, serious systemic disease, including active bacterial or fungal infection.
- •9.Treatment within 3 months of the start of the trial with other immunomodulatory therapy (eg, interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term use of systemic corticosteroids, topical or intra-articular steroids is acceptable, subject to the judgment of the investigator.
- •10.Known hypersensitivity to any of the following: monoclonal antibodies or biologic therapy, pemetrexed or ingredients used in the formulation of pemetrexed, cisplatin or other platinum containing compounds.
- •11.Known allergy or hypersensitivity to oral and/or IV contrast agents, as required for the imaging studies included in this protocol (Section 6.10).
- •12.Breast-feeding, pregnant, or likely to become pregnant during the clinical trial.
- •13.Unwillingness or inability to sign the trial informed consent form (ICF).
研究者
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