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

A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

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 Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500096
      • Apollo Research Foundation
  • Delhi
    • New-Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Healthcare Center Global Hospital
    • Ahmedabad, Gujarat, India, 380054
      • Shalby Hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital and Research Centre
    • Mumbai, Maharashtra, India, 400071
      • Sushrut Hospital & Research Centre
    • Mumbai,, Maharashtra, India, 400012
      • Tata Memorial Hospital
    • Pune, Maharashtra, India, 411001
      • Jehangir Hospital
    • West-Mumbai, Maharashtra, India, 400078
      • Fortis Hospital
  • Orissa
    • Bhubaneswar, Orissa, India, 751007
      • Sparsh Hospital & Critical Care
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625020
      • Apollo Speciality Hospitals
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • IPGME & R / SSKM Hospital
    • Kolkata, West Bengal, India, 700025
      • Health Point Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regorafenib (Stivarga, BAY 73-4506); Patients with metastatic colorectal cancer	Drug: Regorafenib (Stivarga, BAY73-4506); 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).; Other Names: Nublexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body weight (kg)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	Defined as proportion of patients achieving complete response (CR), partial response (PR), or SD (stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1	In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first
Overall response rate (ORR)	Defined as proportion of patients achieving CR, and PR per RECIST v.1.1	In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first
Progression free survival (PFS)	Progression free survival is defined as the time from study drug assignment to progressive disease (PD) or death from any cause or date of last tumor assessment if the patient did not progress or die.	In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first
Overall survival (OS)	Overall survival is defined as the time from study drug assignment to death from any cause or last date when the patient was known to be alive.	In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, they study results according to Bayer's transparency standards.
• Study_Synopsis-19214.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (255.0), Protocol (38.2), Results(0.1)

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: mCRC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 19214 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No