Sorafenib Gastric Cancer Asian Phase I Study
- Registration Number
- NCT00663741
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
- No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
- Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
- Age >/= 18 years and < 75 years
Exclusion Criteria
- Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
- Clinically relevant ascites
- Concurrent cancer that is distinct in primary site or histology from gastric cancer
- Any condition that impairs patient's ability to swallow whole pills
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Sorafenib (Nexavar, BAY43-9006) - Arm 1 Sorafenib (Nexavar, BAY43-9006) - Arm 2 Sorafenib (Nexavar, BAY43-9006) -
- Primary Outcome Measures
Name Time Method Safety and pharmacokinetics 20 weeks after start of treatment
- Secondary Outcome Measures
Name Time Method 1 year survival rate 1 year after start of treatment Overall survival 1 year after start of treatment Progression free survival 1 year after start of treatment Response rate 1 year after start of treatment Duration of response Time from initial Response to documented Tumor Progression