Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy (CONSIGN)

This is an expanded access trial for Colorectal Neoplasms Read More

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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