NCT01128998

Sorafenib Plus S-1 in Advanced Solid Tumors

An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Sorafenib	1. Name: Sorafenib 2. Dosage form: 200 mg / Tablet 3. Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1
DRUG	S-1	1. Name:S-1 2. Dosage form: 20 mg or 25 mg / Capsule 3. Dosing schedule: 20-40 mg/m2 bid,po, 14 days on \& 7 days off

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-11-01
• Completion: 2015-10-01
• First posted: 2010-05-24
• Last updated: 2015-10-19

Locations

1 site across 1 country: Taiwan