The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
204
Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)
Placebo will be given 3 weeks on/1 week off (160 mg od po.)
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: From randomization of the first subject untill 154 death events observed, up to 2 years
Progression-free Survival (PFS)
PFS was defined as the time from date of randomization to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Time frame: From randomization of the first subject untill 154 death events observed, up to 2 years
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).
Time frame: From randomization of the first subject untill 154 death events observed, up to 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
Time frame: From randomization of the first subject untill 154 death events observed, up to 2 years
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: From randomization of the first subject untill 154 death events observed, up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Harbin, Heilongjiang, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Xi'an, Shaanxi, China
Unnamed facility
Qingdao, Shandong, China
Unnamed facility
Chengdu, Sichuan, China
Unnamed facility
Hangzhou, Zhejiang, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
...and 15 more locations