Status:
COMPLETED
Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Lead Sponsor:
Bayer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 provi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01853319
Start Date
July 24 2013
End Date
June 11 2018
Last Update
April 22 2019
Active Locations (11)
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1
Ankara, Turkey (Türkiye), 06100
2
Ankara, Turkey (Türkiye), 06500
3
Antalya, Turkey (Türkiye)
4
Balcali/Adana, Turkey (Türkiye), 01330