To collect the safety and efficacy data in patients with metastatic colorectalcancer after giving regorafenib in Indianpatients.

Phase 4

Completed

• Conditions: Health Condition 1: null- metastatic colorectal cancer mCRC

• Registration Number: CTRI/2018/06/014371
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023
• Study Completion: 2023-09-10

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent

2 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

3 Patients must have PD after receiving the approved standard

therapies

4 Patients must have ECOG PS of 0 or 1 and a life expectancy of atleast 3 months

5 Adequate bone marrow, liver and renal function;

6 Women of childbearing potential and men must agree to use adequate contraception.

Exclusion Criteria

1 Unresolved toxicity greater than Grade 1 from prior treatment for

mCRC

2 Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)

3 Subjects unable to swallow oral medications

Any malabsorption condition;

4 Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patientâ??s participation in the

study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 AEs <br/ ><br>2 changes in ECOG PS from baseline <br/ ><br>3 laboratory changes <br/ ><br>4 changes in vital signsTimepoint: From the start of regorafenib treatment up to 30 days after the last dose of <br/ ><br>regorafenib.

Secondary Outcome Measures

Name	Time	Method
1 Disease control rate defined as proportion of patients achieving CR, <br/ ><br>PR, or SD per RECIST v. 1.1; <br/ ><br>2 Overall response rate defined as proportion of patients achieving CR <br/ ><br>and PR per RECIST v.1.1; <br/ ><br>3 Progression free survival defined as time from treatment assignment <br/ ><br>until PD (per RECIST v. 1.1) or until death; <br/ ><br>4 Overall survival defined as time from treatment assignment until <br/ ><br>death from any cause.Timepoint: The primary completion is reached when each patient has been treated for at least 6 months, <br/ ><br>unless he or she has discontinued treatment earlier. Since the endpoints are dependent on the underlying disease progression the time interval cannot be defined.