Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
REGARD
An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
1 other identifier
interventional
100
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2013
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2018
CompletedApril 22, 2019
April 1, 2019
1.8 years
May 6, 2013
April 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
Regorafenib
EXPERIMENTALRegorafenib, 40 mg tablets
Interventions
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (11)
Unknown Facility
Ankara, 06100, Turkey (Türkiye)
Unknown Facility
Ankara, 06500, Turkey (Türkiye)
Unknown Facility
Antalya, Turkey (Türkiye)
Unknown Facility
Balcali/Adana, 01330, Turkey (Türkiye)
Unknown Facility
Bursa, Turkey (Türkiye)
Unknown Facility
Gaziantep, 27010, Turkey (Türkiye)
Unknown Facility
Istanbul, 34093, Turkey (Türkiye)
Unknown Facility
Istanbul, 34899, Turkey (Türkiye)
Unknown Facility
Izmir, 35100, Turkey (Türkiye)
Unknown Facility
Kayseri, Turkey (Türkiye)
Unknown Facility
Samsun, Turkey (Türkiye)
Related Publications (1)
Dane F, Ozgurdal K, Yalcin S, Benekli M, Aykan NF, Yucel I, Ozkan M, Evrensel T, Sevinc A, Coskun HS, Sanli UA, Kara IO, Yumuk PF. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020 Mar 26;10(3):e027665. doi: 10.1136/bmjopen-2018-027665.
PMID: 32220908DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 15, 2013
Study Start
July 24, 2013
Primary Completion
April 24, 2015
Study Completion
June 11, 2018
Last Updated
April 22, 2019
Record last verified: 2019-04