A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).
Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.
Inclusion Criteria:
Exclusion Criteria:
Capital Federal-Buenos Aires, C1426ANZ, Argentina
Woolloogabba, Queensland 4102, Australia
Bruxelles - Brussel, 1000, Belgium
Bruxelles - Brussel, 1070, Belgium
Bruxelles - Brussel, 1200, Belgium
Hanghzou, 310009, China
Zrifin, Israel 6093000, Israel
Kita-Adachigun, Saitama 362-0806, Japan
Sunto, Shizuoka 411-8777, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Instanbul, 34662, Turkey (Türkiye)