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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00663741 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 36 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
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
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Arm 2: Experimental |
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
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Arm 3: Experimental |
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
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Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
China | |
Not yet recruiting | |
Beijing, China, 100036 | |
Japan, Chiba | |
Recruiting | |
Kashiwa, Chiba, Japan, 277-8577 | |
Japan, Hyogo | |
Recruiting | |
Kobe, Hyogo, Japan, 650-0017 | |
Japan, Tokyo | |
Recruiting | |
Chuo-ku, Tokyo, Japan, 104-0045 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Head Clinical Pharmacology ) |
Study ID Numbers: | 12931 |
Study First Received: | April 17, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00663741 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare; Korea: Food and Drug Administration; China: State Food and Drug Administration |
Unresectable / recurrent gastric cancer Sorafenib S-1 |
Gastric Cisplatin CDDP |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Sorafenib Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |