Sorafenib Gastric Cancer Asian Phase I Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663741

Enrollment

Registered

2008-04-22

Start date

2008-05-31

Completion date

2010-04-30

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Unresectable / recurrent gastric cancer, Sorafenib, S-1, Gastric, Cisplatin, CDDP

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.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and pharmacokinetics	20 weeks after start of treatment

Secondary

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026