Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.

Inclusion Criteria:

• Male or female patients (≥18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically, with measurable metastatic disease according to RECIST v. 1.1
• Patients must have PD after receiving the approved standard therapies
• Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months
• Adequate bone marrow, liver and renal function
• Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

• Unresolved toxicity greater than Grade 1 from prior treatment for mCRC
• Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
• Subjects unable to swallow oral medications
• Any malabsorption condition
• Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study