EUCTR2011-005836-25-CZ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 - CONSIG
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 ³ 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 ³ 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 (³ 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 ³ 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 ³ 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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