Spots Global Cancer Trial Database for Sorafenib Plus S-1 in Advanced Solid Tumors
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Trial Identification
Brief Title: Sorafenib Plus S-1 in Advanced Solid Tumors
Official Title: An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors
Study ID: NCT01128998
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cheng-Kung University Hospital, Tainan City, , Taiwan
Contact Details
Name: Li-Tzong Chen, M.D., Ph.D.
Affiliation: National Institute of Cancer Research, National Health Research Institution, Taiwan
Role: STUDY_CHAIR
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