Sorafenib Plus S-1 in Advanced Solid Tumors

Status Completed

Clinical Trial Summary

Primary Objective:

1. To define the recommended dose for phase II study of S-1 combined with sorafenib

2. To evaluate the dose-limiting toxicities of the combination therapy

Secondary Objectives:

1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy

2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.

3. To determine the changes of biomarkers between pre- and post-treatments.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Advanced Solid Tumors

Clinical Trial Details

NCT number	NCT01128998
Study type	Interventional
Source	National Health Research Institutes, Taiwan
Contact
Status	Completed
Phase	Phase 1
Start date	November 2009
Completion date	October 2015

View Details

See also
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