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

Bayer

Status and phase

Completed

Phase 4

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03564938

19214

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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