Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

Study Overview
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Brief Summary
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This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.

Official Title
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An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

Conditions
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Colorectal Neoplasms

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 subjects >/= 18 years of age Life expectancy of at least 3 months Histological or cytological documentation of adenocarcinoma of the colon or rectum Subjects with metastatic colorectal cancer (Stage IV) Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation) Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1 Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration Exclusion Criteria: Prior treatment with regorafenib Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug Pregnant or breast-feeding subjects Congestive heart failure >/= New York Heart Association (NYHA) class 2 Myocardial infarction less than 6 months before start of study drug Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 Renal failure requiring hemo-or peritoneal dialysis

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<br>Regorafenib, 40 mg tablets | Drug: Regorafenib (Stivarga, BAY73- 4506)<br>* 160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 6 months | 
| Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation |  | Up to 6 months | 
| Number of death |  | Up to 6 months | 
| Number of participants with serious adverse events as a measure of safety and tolerability |  | Up to 6 months | 
| Progression-Free Survival (PFS) | The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regorafenib, Metastatic colorectal cancer