This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.
This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
MAX-40279-01 50mg/70mg
regorafenib
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Disease control rate (DCR)[Part 1]
Time frame: Through study Part 1 completion, an average of 6 months
progress free survival(PFS)[Part 2]
Time frame: Through study Part 1 completion, an average of 6 months
Tmax
Time to maximum plasma concentration
Time frame: Approximately 6 months
Cmax
Maximum plasma drug concentration
Time frame: Approximately 6 months
AUC
Area under the time-concentration curve
Time frame: Approximately 6 months
Objective response rate (ORR)
Time frame: 6 months (anticipated)
overall survival (OS)
Time frame: 24 months
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: 24 months
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