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

Phase 3

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73- 4506)

• Registration Number: NCT01853319
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Study Start: 2013-07-24
• Primary Completion: 2015-04-24
• Study Completion: 2018-06-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regorafenib	Regorafenib (Stivarga, BAY73- 4506)	Regorafenib, 40 mg tablets

Primary Outcome Measures

Name	Time	Method
Number of death	Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation	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)	Up to 6 months	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.
Number of participants with adverse events as a measure of safety and tolerability	Up to 6 months