Trial Condition(s):
Regorafenib in subjects with metastatic colorectal cancer (mCRC) who have progressed after standard therapy (REGARD)
16754
Not Available
Not Available
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.
- 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
- 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
Locations | |
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Locations Investigative Site ISTANBUL, Turkey, 34899 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey, 06500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey, 06100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bursa, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kayseri, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Balcali/Adana, Turkey, 01330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gaziantep, Turkey, 27010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Samsun, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Antalya, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
An open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after standard therapy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1