search
Back to results

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

Primary Purpose

Metastatic Colorectal Cancer

Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Regorafenib (Stivarga, BAY73-4506)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring mCRC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Apollo Research Foundation
  • Sir Ganga Ram Hospital
  • Healthcare Center Global Hospital
  • Tata Memorial Hospital
  • Jaslok Hospital and Research Centre
  • Sushrut Hospital & Research Centre
  • Jehangir Hospital
  • Fortis Hospital
  • Sparsh Hospital & Critical Care
  • Shalby Hospital
  • Apollo Speciality Hospitals
  • IPGME & R / SSKM Hospital
  • Health Point Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regorafenib (Stivarga, BAY 73-4506)

Arm Description

Patients with metastatic colorectal cancer

Outcomes

Primary Outcome Measures

Number of Adverse Events
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Change in Body weight (kg)
Change in Systolic / Diastolic BP (mmHg)
Change in heart rate (beats/min)

Secondary Outcome Measures

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
Overall response rate (ORR)
Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
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.
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.

Full Information

First Posted
May 24, 2018
Last Updated
October 13, 2023
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT03564938
Brief Title
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Official Title
A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
mCRC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib (Stivarga, BAY 73-4506)
Arm Type
Experimental
Arm Description
Patients with metastatic colorectal cancer
Intervention Type
Drug
Intervention Name(s)
Regorafenib (Stivarga, BAY73-4506)
Other Intervention Name(s)
Nublexa
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Title
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Title
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Title
Change in Body weight (kg)
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Title
Change in Systolic / Diastolic BP (mmHg)
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Title
Change in heart rate (beats/min)
Time Frame
From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
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
Time Frame
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
Title
Overall response rate (ORR)
Description
Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
Time Frame
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
Title
Progression free survival (PFS)
Description
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.
Time Frame
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
Title
Overall survival (OS)
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Apollo Research Foundation
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500096
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New-Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Healthcare Center Global Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Sushrut Hospital & Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India
Facility Name
Jehangir Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Fortis Hospital
City
West-Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400078
Country
India
Facility Name
Sparsh Hospital & Critical Care
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751007
Country
India
Facility Name
Shalby Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Apollo Speciality Hospitals
City
Madurai
State/Province
Tamil N?du
ZIP/Postal Code
625020
Country
India
Facility Name
IPGME & R / SSKM Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Health Point Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700025
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

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

We'll reach out to this number within 24 hrs