This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle
Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Chuo-ku, Tokyo, Japan
Safety and pharmacokinetics
Time frame: 20 weeks after start of treatment
1 year survival rate
Time frame: 1 year after start of treatment
Overall survival
Time frame: 1 year after start of treatment
Progression free survival
Time frame: 1 year after start of treatment
Response rate
Time frame: 1 year after start of treatment
Duration of response
Time frame: Time from initial Response to documented Tumor Progression
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