ClinicalTrials.gov
ClinicalTrials.gov Menu

Sorafenib Gastric Cancer Asian Phase I Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00663741
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : June 11, 2013
Sponsor:
Information provided by:
Bayer

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Sorafenib (Nexavar, BAY43-9006) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety and pharmacokinetics [ Time Frame: 20 weeks after start of treatment ]

Secondary Outcome Measures :
  1. 1 year survival rate [ Time Frame: 1 year after start of treatment ]
  2. Overall survival [ Time Frame: 1 year after start of treatment ]
  3. Progression free survival [ Time Frame: 1 year after start of treatment ]
  4. Response rate [ Time Frame: 1 year after start of treatment ]
  5. Duration of response [ Time Frame: Time from initial Response to documented Tumor Progression ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00663741     History of Changes
Other Study ID Numbers: 12931
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

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
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs