Zinc Supplement in Regorafenib Treated mCRC Patient

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Zinc

Criteria

Inclusion Criteria:

• Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib

• Ability to understand and willingness to sign written Informed Consent Form (ICF)

Exclusion Criteria:

• Patients participating in an investigational program with interventions outside of routine clinical practice

• Patients with baseline Zinc level above 120 ug/dL

• Patients with known allergy to Zinc supplementation

• Pregnancy

• Patients who are unsuitable for study participation, based on investigator's discretion