EUCTR2008-005872-29-PT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- Female
入选标准
- •1.Female subjects =18 years of age
- •2.Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. Contraceptive measures must start either prior to or at screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered. Pregnant and/or lactating females are excluded
- •3.A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
- •4.Must have measurable disease by CT or MRI scan
- •5.Must have relapsed radiologically within =6 and = 24 months of completion of first-line platinum/taxane chemotherapy
- •6.Must be a candidate for repeat carboplatin/taxane therapy
- •7.Life expectancy of =6 months as estimated by the investigator
- •8.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
- •9.Karnofsky performance status (KPS) =70%
- •10.Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
- •Absolute neutrophil count (ANC)= 1.5 x 10*9/L
- •Platelet count= 100 x 10*9/L
- •Hemoglobin= 9 g/dL
- •Creatinine=1.5x ULN (CTCAE Grade 1)
- •Bilirubin< 1.5x ULN (CTCAE Grade 1)
- •Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase< 2.5 x ULN (CTCAE Grade 1)
- •11.Neurologic function: neuropathy (sensory and motor) =CTCAE Grade 1
- •12.Subject must provide written informed consent and be able to comply with the protocol procedures
- •(*=to the power)
- •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.Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
- •2.Subjects who have received other therapy to treat their ovarian cancer since relapse
- •3.Known central nervous system (CNS) tumor involvement
- •4.Evidence of other active invasive malignancy requiring treatment in the past 5 years
- •5.Clinically significant heart disease (e.g., 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.Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
- •7.Active serious systemic disease, including active bacterial or fungal infection
- •8.Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.
- •9.Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
- •10.Known allergic reaction to a prior monoclonal antibody therapy or have any documented
- •11.Previous treatment with MORAb-003 (farletuzumab)
- •12.Clinical contraindications to use of a taxane
- •13.Prior treatment with any investigational agent within 4 weeks of study entry
- •14.Breast-feeding, pregnant, or likely to become pregnant during the study
研究者
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