Sorafenib Gastric Cancer Asian Phase I Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00663741

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: Sorafenib (Nexavar, BAY43-9006)	Phase I

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: S 1 (Combination) Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Bayer:

Primary Outcome Measures:

Safety and pharmacokinetics [ Time Frame: 20 weeks after start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1-year survival rate [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]
Response rate [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Time from initial Response to documented Tumor Progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sorafenib (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
Arm 2: Experimental	Drug: Sorafenib (Nexavar, BAY43-9006) 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
Arm 3: Experimental	Drug: Sorafenib (Nexavar, BAY43-9006) 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

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663741

Locations

Japan, Chiba

Kashiwa, Chiba, Japan, 277-8577
Japan, Hyogo

Kobe, Hyogo, Japan, 650-0017
Japan, Tokyo

Chuo-ku, Tokyo, Japan, 104-0045

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Head Clinical Pharmacology )
Study ID Numbers:	12931
Study First Received:	April 17, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00663741 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Korea: Food and Drug Administration; China: State Food and Drug Administration

Keywords provided by Bayer:

Unresectable / recurrent gastric cancer
Sorafenib
S-1

Gastric
Cisplatin
CDDP

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms

Gastrointestinal Neoplasms
Stomach Cancer
Protein Kinase Inhibitors
Sorafenib
Recurrence

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms
Sorafenib

ClinicalTrials.gov processed this record on May 07, 2009