A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

time to progression (TTP)

TTP is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to underlying cancer as per local investigator's assessment.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progression

overall response rate (ORR)

ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

progression free survival (PFS)

PFS is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to any cause as per local investigator's assessment.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

overall survival (OS)

OS is defined as the time from the start date of study treatment to the date of death from any cause.

Time frame: every 8 weeks until death

disease control rate (DCR) per independent central review

Eight-week DCR is as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Time frame: up to 8 weeks after the start date of study treatment

time to progression (TTP) per independent central review

TTP as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

Safety and tolerability of TKI258

Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.

Time frame: more than 30 days after the last date of study treatment

Plasma concentrations of TKI258

Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.

Time frame: Week 1 Day 1 - Day 2: pre-dose (0 hour), 1, 2, 4, 6, 8, and 24 hour (pre-dose). and Week 4 Day 5 - Week 5 Day 1: pre-dose (0 hour), 1, 2, 4, 6, 8, 24, 48, and 72 hour (pre-dose)

overall response rate (ORR) per independent central review

ORR as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress

progression free survival (PFS) per independent central review

PFS as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Time frame: baseline and every 4 weeks until Week 17 and every 8 weeks after Week 17 until disease progress