Sorafenib Gastric Cancer Asian Phase I Study

Phase 1

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• 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

Study Timeline

• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-22
• Study Start: 2008-05
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-09
• Last Update Posted: 2013-06-11

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