This is a phase Ib,single arm,open label study evaluating the safety and efficacy of CT053PTSA in patients with advanced and metastatic renal cell cancer who have progressed from previous treatment
This study is being carried out in two parts,part 1 and part 2. Part 1: This is the dose-escalation part. The primary purpose of the part 1 portion is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the appropriate doses of CT053PTSA for further study Part 2: This is the expansion part.The part 2 portion of this study will continue to evaluate the safety and efficacy of CT053PTSA at the appropriate dose recommended in Part 1,in patients with advanced and metastatic RCC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will received oral CT053PTSA once daily until disease progression or intolerable toxicity or subject's withdrawal from treatment ,each cycle is defined as 28 days
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Part 1(dose-escalation part):Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) of the CT053PTSA will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAEv4.03
Time frame: Cycle 1 Day 1 to Cycle 1 Day 28
Part 2 (expansion part):Overall Response Rate
Overall response rate (ORR),defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST1.1
Time frame: up to approximately 24 months
Number of patients with adverse events (AEs) as a measure of safety and tolerability
Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs
Time frame: up to approximately 24 months
Disease Control Rate (DCR)
DCR, proportion of patients with best overall response of CR, PR or SD
Time frame: up to approximately 24 months
Progression-free Survival (PFS)
PFS, defined as time from date of treatment to disease progression or death due to any cause
Time frame: up to approximately 24 months
Duration of Response (DOR)
DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
Time frame: up to approximately 24 months
Overall Survival (OS)
OS, defined as time from date of treatment to death due to any cause
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Time frame: up to approximately 24 months
Maximum observed plasma concentration (Cmax)
to assess the pharmacokinetic profile
Time frame: Cycle 1 Day1 and Day 28
Time of maximum observed plasma concentration (Tmax)
to assess the pharmacokinetic profile
Time frame: Cycle 1 Day1 and Day 28
Area under the plasma concentration time curve (AUC)
to assess the pharmacokinetic profile
Time frame: Cycle 1 Day1 and Day 28