Sorafenib Plus S-1 in Advanced Solid Tumors

October 16, 2015 updated by: National Health Research Institutes, Taiwan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan City, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
  • Have measurable lesion.
  • 20-75 y/o.
  • ECOG performance score no more than 2.
  • Life expectancy > 12 weeks.

  • Adequate hematopoietic, hepatic and renal functions.

    1. Hemoglobin > 9.0 g/dl
    2. Absolute neutrophil count > 1,500/mm3
    3. Platelet count 100,000/ mm3
    4. Total bilirubin < 1.5 times the upper limit of normal (ULN)
    5. ALT and AST < 2.5 x ULN
    6. Serum creatinine < 1.0 x ULN
  • Recovery from prior therapy that given > 4 weeks before enrolment.
  • No pregnancy and breast-feeding.
  • Signed informed consent.

Exclusion Criteria:

  • Severe cardiovascular disorders.
  • Pulmonary fibrosis or interstitial pneumonia.
  • HIV infection.
  • Active infection.
  • Major anti-cancer treatment within 4 weeks of study entry.
  • Exposure to the current investigational agent before.
  • Known or suspected allergy to the current investigational agent.
  • Unable to swallow oral medications.
  • Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results.
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
  • Symptoms of bowel obstruction, malnutrition, splenomegaly.
  • Receiving active anti-coagulant therapy.
  • Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 and Sorafenib
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
Other Names:
  • Nexavar
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
Other Names:
  • TS-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of MTD/RD
Time Frame: First two cycles
First two cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting Toxicity
Time Frame: First two cycles
First two cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

National Cheng-Kung University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICR-CT2008-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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