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

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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