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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


Phase 1
18 Years
74 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and pharmacokinetics

Outcome Time Frame:

20 weeks after start of treatment

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

12931

NCT ID:

NCT00663741

Start Date:

May 2008

Completion Date:

April 2010

Related Keywords:

  • Gastric Cancer
  • Unresectable / recurrent gastric cancer
  • Sorafenib
  • S-1
  • Gastric
  • Cisplatin
  • CDDP
  • Stomach Neoplasms

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