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Sorafenib Gastric Cancer Asian Phase I Study

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Sorafenib (Nexavar, BAY43-9006)

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Unresectable / recurrent gastric cancer, Sorafenib, S-1, Gastric, Cisplatin, CDDP

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Safety and pharmacokinetics

Secondary Outcome Measures

1 year survival rate

Overall survival

Progression free survival

Response rate

Duration of response

Full Information

NCT ID

NCT00663741

First Posted

April 17, 2008

Last Updated

June 9, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00663741

Brief Title

Sorafenib Gastric Cancer Asian Phase I Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sorafenib (Nexavar, BAY43-9006)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sorafenib (Nexavar, BAY43-9006)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sorafenib (Nexavar, BAY43-9006)

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and pharmacokinetics

Time Frame

20 weeks after start of treatment

Secondary Outcome Measure Information:

Title

1 year survival rate

Time Frame

1 year after start of treatment

Title

Overall survival

Time Frame

1 year after start of treatment

Title

Progression free survival

Time Frame

1 year after start of treatment

Title

Response rate

Time Frame

1 year after start of treatment

Title

Duration of response

Time Frame

Time from initial Response to documented Tumor Progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

12. IPD Sharing Statement

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Sorafenib Gastric Cancer Asian Phase I Study

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