Trial Condition(s):

Metastatic Colorectal Cancer

Regorafenib in Indian patients with metastatic colorectal cancer (mCRC).

Bayer Identifier:

19214

ClinicalTrials.gov Identifier:

NCT03564938

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Fortis Hospital

West-Mumbai, India, 400078

Status
Completed
 
Locations

Health Point Hospital

Kolkata, India, 700025

Status
Active, not recruiting
 
Locations

Tata Memorial Hospital

Mumbai, India, 400012

Status
Active, not recruiting
 
Locations

Sir Ganga Ram Hospital

New-Delhi, India, 110060

Status
Active, not recruiting
 
Locations

IPGME & R / SSKM Hospital

Kolkata, India, 700020

Status
Active, not recruiting
 
Locations

Apollo Speciality Hospitals

Madurai, India, 625020

Status
Completed
 
Locations

Jaslok Hospital and Research Centre

Mumbai, India, 400026

Status
Completed
 
Locations

Jehangir Hospital

Pune, India, 411001

Status
Active, not recruiting
 
Locations

Healthcare Center Global Hospital

Ahmedabad, India, 380060

Status
Active, not recruiting
 
Locations

Sparsh Hospital & Critical Care

Bhubaneswar, India, 751007

Status
Active, not recruiting
 
Locations

Shalby Hospital

Jaipur, India, 302021

Status
Completed
 
Locations

Sushrut Hospital & Research Centre

Mumbai, India, 400071

Status
Active, not recruiting
 
Locations

Apollo Research Foundation

Hyderabad, India, 500096

Status
Active, not recruiting
 

Trial Design