Primary Objective: \- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens Secondary Objectives: * To determine the RD of cabazitaxel when administered as a single agent every 3 weeks * To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks * To estimate the overall survival (OS) and progression free survival (PFS) * To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1
Patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed during and after the study treatment until death or the end of study, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Pharmaceutical form: solution for infusion Route of administration: intravenous
Investigational Site Number 410001
Seoul, South Korea
Objective Response Rate
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to a maximum of 2 years
Progression free survival (PFS)
Time frame: Up to a maximum of 2 years
Number of patients with adverse events
Time frame: Up to a maximum of 2 years
Pharmacokinetic parameter: Cmax
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter tmax
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter t1/2z
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter AUC
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter AUClast
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter CL
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter Vss
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
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