Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapy
- Conditions
- Colorectal neoplasmsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005836-25-ES
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2872
- 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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method