EUCTR2011-005836-25-ES进行中（未招募）1 期
An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,872
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
- •- Male or female subjects >= 18 years of age.
- •- Life expectancy of at least 3 months
- •- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- •-Subjects with metastatic colorectal cancer (Stage IV).
- •- Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
- •-ECOG Performance Status of <= 1 (ECOG: Eastern Cooperative Oncology Group)
- •-Adequate bone marrow, liver and renal function
- •-Women of childbearing potential and men must agree to use adequate contraception
- •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 1650
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1350
排除标准
- •-Prior treatment with regorafenib.
- •-Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication treatment
- •-Pregnant or breast-feeding subjects.
- •-Congestive heart failure >= New York Heart Association (NYHA) class 2.
- •-Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
- •-Myocardial infarction less than 6 months before start of study drug.
- •-Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •-Uncontrolled hypertension. (Systolic blood pressure>140 mmHg or diastolic pressure >90 mmHg despite optimal medical management).
- •-Pleural effusion or ascites that causes respiratory compromise (>=CTCAE Grade 2 dyspnea). (CTCAE: common terminology criteria for adverse events)
- •-Ongoing infection >Grade 2 CTCAE v. 4.0.
- •-Known history of human immunodeficiency virus (HIV) infection.
- •-Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- •-Subjects with seizure disorder requiring medication.
- •-Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
- •-Any hemorrhage or bleeding event >= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
- •-Non-healing wound, ulcer, or bone fracture.
- •-Renal failure requiring hemo-or peritoneal dialysis.
- •-Dehydration CTCAE v. 4.0 Grade >=1.
- •-Interstitial lung disease with ongoing signs and symptoms
- •-Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
- •-Any malabsorption condition.
- •-Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity <=Grade 2.
- •-Concomitant participation or participation within the last 30 days in another clinical trial
- •-Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.
研究者
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