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NCT Number: NCT00663741

Sorafenib Gastric Cancer Asian Phase I Study

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

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

Primary outcomes

  1. Safety and pharmacokinetics

    Time frame: 20 weeks after start of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2008
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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