Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 760
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC). arm 2: Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).

Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: 160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off) intervention 2: matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off) intervention 3: BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.

Protocol document: