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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRC