Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Prior treatment with regorafenib
Congestive heart failure \>/= New York Heart Association (NYHA) class 2
Uncontrolled hypertension (Systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management)
Any hemorrhage or bleeding event \>/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
Persistent proteinuria of CTCAE Grade 3 (\>3.5g/24 hours)
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
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
Clareo Health | Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
