MedTrace Logo

Sorafenib Gastric Cancer Asian Phase I Study

NCT00663741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-06-11

No results posted yet for this study

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.

Conditions

Interventions

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663741 on ClinicalTrials.gov