Sorafenib Plus S-1 in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128998
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : October 19, 2015
National Cheng-Kung University Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

May 20, 2010
May 24, 2010
October 19, 2015
November 2009
November 2009   (Final data collection date for primary outcome measure)
Determination of MTD/RD [ Time Frame: First two cycles ]
Same as current
Complete list of historical versions of study NCT01128998 on Archive Site
Dose-limiting Toxicity [ Time Frame: First two cycles ]
Same as current
Not Provided
Not Provided
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

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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • 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 Name: 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 Name: TS-1
Experimental: S-1 and Sorafenib
  • Drug: Sorafenib
  • Drug: S-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2015
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital
Study Chair: Li-Tzong Chen, M.D., Ph.D. National Institute of Cancer Research, National Health Research Institution, Taiwan
National Health Research Institutes, Taiwan
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP