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Sorafenib Gastric Cancer Asian Phase I Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00663741
First received: April 17, 2008
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Experimental: Arm 2 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
Experimental: Arm 3 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
Kashiwa, Chiba, Japan, 277-8577
Kobe, Hyogo, Japan, 650-0017
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

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00663741     History of Changes
Other Study ID Numbers: 12931
Study First Received: April 17, 2008
Last Updated: June 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Bayer:
Unresectable / recurrent gastric cancer
Sorafenib
S-1
 Gastric
Cisplatin
CDDP

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013