EUCTR2011-004687-30-IT进行中（未招募）不适用
APOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer. - NAPOLI 1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •Histologically or cytologically confirmed adenocarcinoma of
- •exocrine pancreas
- •Documented metastatic disease; disease status may be measurable or
- •non-measurable as defined by RECIST v1.1 guidelines
- •Documented disease progression after prior gemcitabine or
- •gemcitabine containing therapy, in locally advanced or metastatic
- •setting. Examples of permitted therapies include, but are not limited to:
- •o Single agent gemcitabine
- •o Any one gemcitabine-based regimen, with or without
- •maintenance gemcitabine
- •o Single agent gemcitabine to which a platinum agent, a
- •fluoropyrimidine, or erlotinib was subsequently added
- •o Gemcitabine administered in the adjuvant setting if disease
- •recurrence occurred within 6 months of completing the
- •adjuvant therapy.
- •(for complete list see the protocol).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Prior irinotecan treatment
- •Active CNS metastases (indicated by clinical symptoms, cerebral
- •edema, steroid requirement, or progressive disease)
- •Clinically significant gastrointestinal disorder including hepatic
- •disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- •History of any second malignancy in the last 5 years; subjects with
- •prior history of in-situ cancer or basal or squamous cell skin cancer are
- •eligible. Subjects with other malignancies are eligible if they have been
- •continuously disease free for at least 5 years.
- •Major surgery or radiotherapy within 4 weeks of enrollment
- •Severe arterial thromboembolic events (myocardial infarction,
- •unstable angina pectoris, stroke) less than 6 months before inclusion.
研究者
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