Sorafenib Gastric Cancer Asian Phase I Study

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* 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<br>|
| Experimental: Arm 2<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* 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<br>|
| Experimental: Arm 3<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and pharmacokinetics |  | 20 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable / recurrent gastric cancer, Sorafenib, S-1, Gastric, Cisplatin, CDDP