EUCTR2011-005836-25-IT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
- 性别
- All
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: 0
- •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
相似试验
进行中（未招募）
1 期
Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapyColorectal neoplasmsEUCTR2011-005836-25-NLBayer HealthCare AG2,872
进行中（未招募）
1 期
Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapyColorectal neoplasmsEUCTR2011-005836-25-CZBayer HealthCare AG2,872
进行中（未招募）
1 期
Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapyColorectal neoplasmsEUCTR2011-005836-25-ESBayer HealthCare AG2,872
进行中（未招募）
1 期
Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapyColorectal neoplasmsEUCTR2011-005836-25-SEBayer HealthCare AG2,872
进行中（未招募）
1 期
Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapyColorectal neoplasmsEUCTR2011-005836-25-PTBayer HealthCare AG2,872