check_circleStudy Completed

Gastric Cancer

Bayer Identifier:

12931

ClinicalTrials.gov Identifier:

NCT00663741

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sorafenib Gastric Cancer Asian Phase I study

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 74 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
13
Trial Dates
May 2008 - April 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
National Cancer Center Central HospitalChuo-ku, 104-0045, Japan
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Completed
Kobe University HospitalKobe, 650-0017, Japan

Primary Outcome

  • Safety and pharmacokinetics
    date_rangeTime Frame:
    20 weeks after start of treatment
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    Safety Issue:
    yes

Secondary Outcome

  • 1 year survival rate
    date_rangeTime Frame:
    1 year after start of treatment
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    Safety Issue:
    no
  • Overall survival
    date_rangeTime Frame:
    1 year after start of treatment
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    Safety Issue:
    no
  • Progression free survival
    date_rangeTime Frame:
    1 year after start of treatment
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    Safety Issue:
    no
  • Response rate
    date_rangeTime Frame:
    1 year after start of treatment
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    Safety Issue:
    no
  • Duration of response
    date_rangeTime Frame:
    Time from initial Response to documented Tumor Progression
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    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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