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Sorafenib Plus S-1 in Advanced Solid Tumors

NCT01128998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-10-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, M.D., Ph.D. · National Institute of Cancer Research, National Health Research Institution, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-11-30
Completion
2015-10-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT01128998 on ClinicalTrials.gov