Sorafenib Gastric Cancer Asian Phase I Study | NCT00663741

Studies
Sorafenib Gastric Cancer Asian Phase I Study

NCT00663741

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 11, 2013Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Gastric Cancer

Interventions

Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Apr 17, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: Sorafenib (Nexavar, BAY43-9006)
Arm 2	Experimental	Drug: Sorafenib (Nexavar, BAY43-9006)
Arm 3	Experimental	Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib (Nexavar, BAY43-9006)	Drug	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	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Kashiwa	Chiba	277-8577	Japan