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

Bayer100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Metastatic Colorectal Cancer

Interventions

Regorafenib (Stivarga, BAY73-4506)DRUG

The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Apollo Research Foundation

Hyderabad, Andhra Pradesh, India

Shalby Hospital

Ahmedabad, Gujarat, India

Healthcare Center Global Hospital

Ahmedabad, Gujarat, India