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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).
Bayer Study Director
Germany: Federal Institute for Drugs and Medical Devices
|Hinsdale, Illinois 60521|
|Bettendorf, Iowa 52722|
|Alexandria, Minnesota 56308|
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Columbia, Missouri 65203|
|Albany, New York 12208|
|Cleveland, Ohio 44195|
|Philadelphia, Pennsylvania 19104|
|Austin, Texas 78705|
|Flint, Michigan 48532|
|Hackensack, New Jersey 07601|
|Metairie, Louisiana 70006|
|Charleston, South Carolina|
|Bismarck, North Dakota 58501|
|Salt Lake City, Utah 84112|