Study Completed

Gastric Cancer

Bayer Identifier:

12931

ClinicalTrials.gov Identifier:

NCT00663741

EudraCT Number:

Not Available

EU CT Number:

Not Available

Sorafenib Gastric Cancer Asian Phase I study

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 74 Years

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

Trial summary

Enrollment Goal

Trial Dates

May 2008 - April 2010

Phase

Phase 1

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	National Cancer Center Central Hospital	Chuo-ku, 104-0045, Japan
Completed	National Cancer Center Hospital East	Kashiwa, 277-8577, Japan
Completed	Kobe University Hospital	Kobe, 650-0017, Japan

Primary Outcome

Safety and pharmacokinetics
Time Frame:
20 weeks after start of treatment
Safety Issue:
yes

Secondary Outcome

1 year survival rate
Time Frame:
1 year after start of treatment
Safety Issue:
no
Overall survival
Time Frame:
1 year after start of treatment
Safety Issue:
no
Progression free survival
Time Frame:
1 year after start of treatment
Safety Issue:
no
Response rate
Time Frame:
1 year after start of treatment
Safety Issue:
no
Duration of response
Time Frame:
Time from initial Response to documented Tumor Progression
Safety Issue:
no

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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