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

Colorectal Neoplasms Clinical Trial

— REGARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853319
• Other study ID #: 16754
• Status: Completed
• Phase: Phase 3
• Start date: July 24, 2013
• Est. completion date: June 11, 2018

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 11, 2018
• Est. primary completion date: April 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73- 4506)
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		Up to 6 months
Primary	Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation		Up to 6 months
Primary	Number of death		Up to 6 months
Primary	Number of participants with serious adverse events as a measure of safety and tolerability		Up to 6 months
Primary	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

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